Takeda is a patient-focused, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future.

&#21313;&#22823;&#32593;&#36172;&#24179;&#21488;制药:全球主页

一个拿着马克杯盯着天空的女人

# Mexico assistance program reaches patients ‘from cities to the most rural villages’

* ***Approval Based on Results from Positive, Global, Phase 3 FRESCO-2 Trial***

* ***FRUZAQLA (fruquintinib) is the First Novel Targeted Therapy in Japan for Metastatic Colorectal Cancer (mCRC) Regardless of Biomarker Status in Over a Decade***

**OSAKA, Japan and CAMBRIDGE, Massachusetts, 2024年9月24日** – Takeda ([TSE:4502/NYSE:TAK](http://cts.businesswire.com/ct/CT?id=smartlink\&url=http%3A%2F%2Fc.um-care.com%2Finvestors%2F\&esheet=52286207\&newsitemid=20200915005224\&lan=en-US\&anchor=TSE%3A4502%2FNYSE%3ATAK\&index=2\&md5=b7076f2bbb02ad331cdf76657f8aa07f)) today announced that it has received approval from the Japanese Ministry of Health, Labour and Welfare to manufacture and market FRUZAQLA Capsules 1mg/5mg (generic name: fruquintinib), a selective oral inhibitor of vascular endothelial growth factor receptor (VEGFR) -1, -2 and -3, for the treatment of advanced or recurrent colorectal cancer (CRC) that is neither curable nor resectable and that has progressed after chemotherapy.

The approval is based primarily on the results of the FRESCO-2 trial, a global Phase 3 clinical trial conducted in the United States, Europe, Japan and Australia. The trial compared FRUZAQLA plus best supportive care (BSC) with placebo plus BSC in patients with previously treated metastatic colorectal cancer (mCRC). The FRESCO-2 trial met all primary and key secondary efficacy endpoints and demonstrated consistent benefits in patients who received FRUZAQLA, regardless of the types of therapy the patients had previously received. FRUZAQLA demonstrated a manageable safety profile in the FRESCO-2 trial, with the incidence of adverse events leading to discontinuation being 21% in the placebo plus BSC arm compared to 20% in the FRUZAQLA plus BSC arm.1 The data from the FRESCO-2 trial were [published](http://www.thelancet.com/journals/lancet/article/PIIS0140-6736$23$00772-9/abstract) in The Lancet in June 2023.

Dr. Takayuki Yoshino, deputy director of hospital, head, Division for the Promotion of Drug and Diagnostic Development, and chief, Department of Gastrointestinal 肿瘤学 at the National Cancer Center Hospital East, who served on the FRESCO-2 study Steering Committee, said, “Although the mortality rate of colorectal cancer has been going down in recent years due to early screening and advances in treatment, the 5-year survival rate for metastatic colorectal cancer remains low and new treatment options are much in need. The approval of FRUZAQLA in Japan offers new hope for patients and families of patients with metastatic colorectal cancer, as well as for healthcare personnel involved in colorectal cancer treatment. I feel that it is of great clinical significance.”

“For more than a decade, Takeda has been a leader in advancing the treatment of metastatic colorectal cancer in Japan. With this approval of FRUZAQLA, we are able to further support patients living with this debilitating disease,” said Teresa Bitetti, president of the Global 肿瘤学 Business Unit at Takeda. “FRUZAQLA is now approved in the U.S., European Union, Japan and a number of other countries around the world, and we remain committed to bringing this treatment to additional patients with metastatic colorectal cancer around the world who urgently need new therapeutic options.”

## 关于 FRUZAQLA (fruquintinib)

FRUZAQLA is a selective oral inhibitor of all three VEGF receptors (-1, -2 and -3). VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. FRUZAQLA was designed to have enhanced selectivity that limits off-target kinase activity, allowing for drug exposure achieving sustained target inhibition and flexibility for potential use as part of combination therapy.

Takeda has the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong and Macau. FRUZAQLA was approved by the U.S. Food and Drug Administration (FDA) in November 2023 and by the European Commission (EC) in June 2024. Fruquintinib is developed and marketed in China by HUTCHMED. Fruquintinib was approved for marketing by the China National Medical 产品 Administration (NMPA) in September 2018 and commercially launched in China in November 2018 under the brand name ELUNATE®.

## JAPAN IMPORTANT SAFETY INFORMATION

Please consult the FRUZAQLA (fruquintinib) Japan package insert (J-PI) before prescribing.

**WARNING:** FRUZAQLA should be administered only to patients for whom the use of FRUZAQLA is considered appropriate under the supervision of a physician with sufficient knowledge of and experience in cancer chemotherapy at a medical institution where adequate emergency care can be provided. Prior to treatment initiation, the efficacy and risks should be fully explained to the patient and/or his/her family and informed consent should be obtained; Severe gastrointestinal hemorrhage, including fatal cases, has been reported. 病人 should be carefully monitored, and if any abnormalities are observed, administration of FRUZAQLA should be withheld and appropriate measures should be taken. If severe hemorrhage occurs, FRUZAQLA should not be re-administered; Gastrointestinal perforation has been reported with some fatal cases. 病人 should be carefully monitored, and if any abnormalities are observed, administration of FRUZAQLA should be withheld and appropriate measures should be taken. If gastrointestinal perforation occurs, FRUZAQLA should not be re-administered.

**CONTRAINDICATIONS:** 病人 with a history of hypersensitivity to any of the ingredients of FRUZAQLA.

**IMPORTANT PRECAUTIONS:** Hypertension, including hypertensive crisis, may occur. Blood pressure should be measured prior to the initiation of FRUZAQLA treatment and periodically during this treatment; Proteinuria may occur. Urinary protein should be monitored prior to the initiation of FRUZAQLA treatment and periodically during this treatment; If a surgical procedure is to be performed, patients are recommended to withhold FRUZAQLA before the surgery because wound healing may be delayed. Treatment resumption after the surgical procedure should be determined depending on the patient's condition upon confirmation of adequate wound healing.

**PRECAUTIONS CONCERNING PATIENTS WITH SPECIFIC BACKGROUNDS: 病人 with hypertension:** Hypertension may worsen; **病人 with bleeding diathesis or abnormal coagulation system:** Hemorrhagic events may occur; **病人 with hemorrhage such as gastrointestinal hemorrhage:** Hemorrhage may be enhanced; **病人 with a complication of intra-abdominal inflammation in the gastrointestinal tract, etc.:** Gastrointestinal perforation may occur; **病人 with current or a history of thromboembolism:** Transient ischaemic attack, thrombotic microangiopathy, pulmonary embolism, portal vein thrombosis, deep vein thrombosis, etc. may occur; **病人 with severe hepatic impairment (Child-Pugh Class C):** Since FRUZAQLA is metabolized mainly in the liver, blood concentrations may be increased. There have been no clinical studies conducted in patients with severe hepatic impairment; **病人 with Reproductive Potential:** Women of childbearing potential should be advised to use adequate contraception during treatment with FRUZAQLA and for 2 weeks after the last dose; **Pregnant Women:** FRUZAQLA can be administered to women who are or may be pregnant only if the expected therapeutic benefits outweigh the possible risks associated with this treatment. In a rat embryo-fetal toxicity study, fetal abnormalities and teratogenic effects consisting of fetal external, visceral, and skeletal malformations and visceral and skeletal variations were observed at exposure levels approximately 0.05 times the exposure level (AUC) of FRUZAQLA at the maximum clinical dose (5 mg/day); **Breast-feeding Women:** It is advisable not to breastfeed. FRUZAQLA may pass into breast milk, and infants may experience serious adverse reactions if they are ingested through breast milk; **Pediatric Use:** There have been no clinical studies conducted in pediatric patients.

## ADVERSE REACTIONS:

Any of the adverse reactions listed below may occur. 病人 should be closely monitored, and if any such abnormalities are observed, appropriate measures should be taken, including treatment discontinuation. Clinically Significant Adverse Reactions are follows.

**Hypertension:** Hypertension or hypertensive crisis may occur. If an increase in blood pressure is observed, appropriate treatment such as antihypertensive drug administration should be given as necessary, and if necessary, the dose of fruquintinib should be reduced, or fruquintinib administration should be interrupted. If severe or persistent hypertension, or hypertension that cannot be controlled by routine antihypertensive therapy occurs or if a hypertensive crisis occurs, fruquintinib administration should be discontinued; **Skin disorder:** Skin disorder including palmar-plantar erythrodysesthesia syndrome and rash may occur; **Hemorrhage:** Hemorrhage including epistaxis, hematuria, gastrointestinal hemorrhage and hemoptysis may occur. Fatal outcomes have been reported; **Gastrointestinal perforation:** Fatal outcomes have been reported; **Arterial thromboembolic events:** Arterial thromboembolic events including transient ischemic attack and thrombotic microangiopathy may occur; **Venous thromboembolism events:** Venous thromboembolism such as pulmonary embolism, portal vein thrombosis, and deep vein thrombosis may occur; **Posterior reversible encephalopathy syndrome:** If headaches, convulsions, lethargy, confusion, changes in mental function, blindness or other visual disturbances, or neurological impairment are observed, fruquintinib administration should be discontinued, and appropriate measures should be taken, including blood pressure control; **Arterial dissection:** Arterial dissection including aortic dissection may occur.

**For US Prescribing Information:** <http://www.fruzaqla.com/sites/default/files/resources/fruzaqla-prescribing-information.pdf>

**For European Union Summary of Product Characteristics:** <http://www.ema.europa.eu/en/medicines/human/EPAR/fruzaqla>

## 关于 the Phase 3 FRESCO-2 Trial

The FRESCO-2 study is a multi-regional clinical trial conducted in the U.S., Europe, Japan and Australia investigating FRUZAQLA plus BSC vs placebo plus BSC in patients with previously treated mCRC ([NCT04322539](http://clinicaltrials.gov/study/NCT04322539)). The study met all of its primary and key secondary endpoints, demonstrating that treatment with FRUZAQLA resulted in statistically significant and clinically meaningful improvement in overall survival and progression-free survival. The safety profile of FRUZAQLA in FRESCO-2 was consistent with previously reported fruquintinib monotherapy studies. Results from the study were [presented](http://oncologypro.esmo.org/meeting-resources/esmo-congress-2022/fresco-2-a-global-phase-iii-multiregional-clinical-trial-mrct-evaluating-the-efficacy-and-safety-of-fruquintinib-in-patients-with-refractory-met) at ESMO in September 2022 and subsequently [published](http://www.thelancet.com/journals/lancet/article/PIIS0140-6736$23$00772-9/abstract) in *The Lancet* in June 2023.2,1

## Takeda’s Commitment to Colorectal Cancer in Japan

CRC is the most prevalent type of cancer in Japan, with an estimated 161,000 new cases and 54,000 deaths in 2023, according to the National Cancer Center’s statistics.3 While early-stage CRC can be surgically resected, mCRC remains an area of high unmet need with patients awaiting new treatment options, given its poor prognosis and limited treatment options.4-8 For over a decade, we have contributed to the treatment of patients with late-stage CRC who have limited treatment options and to the advancement of personalized treatment through the provision of innovative medicines and the generation of relevant evidence. Moving forward, we will continue our work to treat patients with CRC and address their unmet needs.

## 关于 Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R\&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, 我们的人民和地球. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit [c.um-care.com](http://c.um-care.com).

## Media Contacts:

**Japanese Media**

Akiko Manome

<akiko.manome@um-care.com>

**U.S. and International Media**

Emma Nash

<emma.nash@um-care.com>

## Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

## Forward-Looking 语句

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: <http://c.um-care.com/investors/sec-filings-and-security-reports/> or at [www.sec.gov](http://www.sec.gov). Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

## Medical Information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

## References:

1. Dasari NA, et al. Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2): an international, multicentre, randomised, double-blind, phase 3 study. Lancet. 2023;402(10395):41-53. doi:10.1016/S0140-6736(23)00772-9.
2. Dasari NA, et al. LBA25 – FRESCO-2: A global phase 3 multiregional clinical trial (MRCT) evaluating the efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer. Ann Oncol. 2022 Sep;33(suppl\_7): S808-S869. Doi:10.1016/annonc/annonc1089.
3. Foundation for Promotion of Cancer Research. Cancer Statistics In Japan. Tokyo, Foundation for Promotion of Cancer Research; 2023.
4. Bando H, et al. Therapeutic landscape and future direction of metastatic colorectal cancer. Nat Rev Gastroenterol Hepatol 2023; 20(5)306-322. doi:10.1038/s41575-022-00736-1.
5. D'Haene N, et al. Clinical application of targeted next-generation sequencing for colorectal cancer patients: a multicentric Belgian experience. Oncotarget. 2018;9(29):20761-20768. Published 2018 Apr 17. doi:10.18632/oncotarget.25099.
6. Venderbosch, et al. Mismatch repair status and braf mutation status in metastatic colorectal cancer patients: A pooled analysis of the Cairo, Cairo2, coin, and Focus Studies. Clinical Cancer Res.,2014; 20(20):5322–5330. doi:10.1158/1078-0432.ccr-14-0332.
7. Koopman, M., et al. Deficient mismatch repair system in patients with sporadic advanced colorectal cancer. Br J Cancer. 209;100(2), 266–273. doi:10.1038/sj.bjc.6604867.
8. Ahcene Djaballah S, et al. HER2 in Colorectal Cancer: The Long and Winding Road From Negative Predictive Factor to Positive Actionable Target.Am Soc Clin Oncol Educ Book. 2022;42:1-14. doi:10.1200/EDBK\_351354.

Takeda announces Japanese Ministry of Health approval for FRUZAQLA (fruquintinib) to treat unresectable advanced or recurrent colorectal cancer, based on positive Phase 3 FRESCO-2 trial results.

日本批准&#21313;&#22823;&#32593;&#36172;&#24179;&#21488;FRUZAQLA (fruquininib)治疗晚期或复发性结直肠癌

*	***Presentations Include New Data from the TAK-861-2001 Phase 2b Trial in Narcolepsy Type 1 Highlighting Impact on Daily Functioning Including Cognition and Sleep Quality***
*	***Data from Long-Term Extension Study will also be Presented***
*	***Phase 3 Trial of an Orexin Agonist for Narcolepsy Type 1 Now Enrolling 病人 Globally***

**OSAKA, Japan and CAMBRIDGE, Massachusetts, September, 19, 2024** – Takeda ([TSE:4502/NYSE:TAK](http://c.um-care.com/investors/overview/)) will present additional data from the Phase 2b trials (TAK-861-2001, TAK-861-2002) and long-term extension (LTE) study (TAK-861-2003) of TAK-861 in narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2) at Sleep Europe 2024, the 27th Congress of the European Sleep Research Society (ESRS), being held September 24-27, 2024 in Seville, Spain. TAK-861 is an investigational oral orexin receptor 2 (OX2R) selective-agonist designed to address the orexin deficiency in NT1 by selectively stimulating the orexin receptor 2. TAK-861 has the potential to be the first treatment to address the underlying pathophysiology of NT1. Based on the positive Phase 2b trial results, Takeda has initiated the FirstLight Study, a global Phase 3 trial evaluating the efficacy and safety of TAK-861 in adults with NT1.

Takeda’s scientific presentations will include a podium presentation highlighting the effect of TAK-861 on cognitive impairment (Abstract No: 781) along with several poster presentations from additional exploratory endpoints including impacts on quality of nocturnal sleep and sustained attention. An interim analysis of safety and efficacy from the ongoing LTE study (Poster No: P1291) will also be presented. 

“People living with narcolepsy suffer from debilitating symptoms that significantly impact their daily life beyond excessive daytime sleepiness and cataplexy,” said Elena Koundourakis, head, orexin franchise development & neuroscience programs and portfolio strategy at Takeda. “As leaders in orexin science, we continue to develop one of the most extensive clinical datasets of orexin agonists, with some patients reaching one year of treatment within our clinical studies. The data we are presenting at Sleep Europe add to the body of orexin agonist data we are building to improve our understanding of orexin biology and the potential of our investigative study drug TAK-861 towards establishing a new standard of care for the NT1 community.”

These data presentations add to the scientific community's growing understanding of the potential of OX2R agonists  in redefining treatment outcomes for patients with NT1. Takeda is continuing the development of tailored assets to address the needs of people living with sleep-wake disorders including narcolepsy type 2 and idiopathic hypersomnia.

More information on the FirstLight Study, which is currently enrolling, can be found at [www.clinicaltrials.gov](http://www.clinicaltrials.gov) (identifier: NCT06470828) and [www.firstlightstudy.com](http://www.firstlightstudy.com) (for U.S. Audiences only). Takeda does not have any approved therapies for narcolepsy.

## 关于 Takeda’s Orexin Agonists for Sleep-Wake Disorders
Takeda is advancing the field of orexin therapeutics with a multi-asset franchise offering tailored treatments to unlock the full potential of orexin science. Orexin is a key regulator of the sleep-wake cycle and is involved in other essential functions, including respiration and metabolism. TAK-861 is the leading program in this franchise and received Breakthrough Therapy designation for the treatment of excessive daytime sleepiness in narcolepsy type 1 from the U.S. Food and Drug Administration (FDA). The company is also progressing  orexin agonists in patient populations with normal levels of orexin neuropeptides and other indications where orexin biology is implicated. This includes TAK-360, an oral OX2R agonist being investigated for narcolepsy type 2 and idiopathic hypersomnia, which recently initiated a Phase 1 trial and received Fast Track designation from the  FDA.

## 关于 Takeda 
Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, 我们的人民和地球. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit [c.um-care.com](http://c.um-care.com).

### Media Contacts:

#### Japanese Media

Jun Saito

[jun.saito@um-care.com](mailto:jun.saito@um-care.com)

#### U.S. and International Media

Rachel Wallace

[rachel.wallace2@um-care.com ](mailto:rachel.wallace2@um-care.com )

## Important Notice
For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

## Forward-Looking 语句
This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: [http://c.um-care.com/investors/sec-filings-and-security-reports/](http://c.um-care.com/investors/sec-filings-and-security-reports/) or at [http://www.sec.gov/](http://www.sec.gov/). Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

## Medical Information
This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

Takeda will present additional data from the Phase 2 trials and long-term extension (LTE) study of TAK-861 in narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2)   at Sleep Europe 2024, the 27th Congress of the European Sleep Research Society (ESRS), being held September 24-27, 2024 in Seville, Spain. 

&#21313;&#22823;&#32593;&#36172;&#24179;&#21488;将在2024年欧洲睡眠大会上公布额外的临床试验研究数据，强调食欲素激动剂TAK-861对发作性睡病负担的影响

* *More Than 22,000 Takeda Employees Selected the FY2024 New Partners: Population Services International, Bulungula Incubator, Reach Out Cameroon, Seed Global Health and VillageReach*

* *Takeda’s Five New Partnerships Boost Total Global CSR Program Contributions to JPY 28.8 Billion (Approx. USD 199.1 million) Across 34 Diverse Partnerships Worldwide and extend our reach to an additional 2 million direct beneficiaries*

* *Takeda’s Global CSR Program Expects to Reach 27 Million People in 93 Countries by 2030*

**OSAKA, Japan and CAMBRIDGE, Massachusetts, 2024年9月18日 – Takeda (**[**TSE:4502/NYSE: TAK**](http://c.um-care.com/investors/overview/)**)**
today committed JPY4.6 billion (Approx. USD 32 million) to five new Global Corporate Social Responsibility (CSR) partners as part of the company’s ongoing commitment to improving health systems resiliency in low and middle-income countries around the world. This commitment demonstrates Takeda’s focus on tackling systemic disparities and supporting local leadership in strengthening health infrastructure, empowering health workforce, and increasing local knowledge and capacity to improve equitable and sustainable healthcare access and delivery.

By 2030, these new collaborations are anticipated to extend Takeda’s impact to 27 million people across 93 countries, raising the total contributions from Takeda’s Global CSR Program to over JPY 28.8 billion (Approx. USD 199.1 million) across 34 significant partnerships since it began in 2016. The five new partners were selected by more than 22,000 Takeda employees across 80 countries and regions through a company-wide vote, highlighting the company’s commitment to a collaborative and inclusive approach in its global corporate giving initiative.

“Since our founding in 1781, Takeda has put patients, people and society at the center of its business decisions. We are committed to being a respected partner, making a long-term contribution to society to address health challenges worldwide. Our Global CSR Program has served as a strong demonstration of this commitment since 2016.” said Takako Ohyabu, chief global corporate affairs and sustainability officer at Takeda. “I’m particularly proud of each of our new partners’ thoughtful commitment to equity, scalability and sustainability as cornerstones of health systems resiliency. These long-term partnerships will not only deliver tangible impact, but they will also share invaluable lessons, creating a ripple effect of innovation and improved health outcomes for people worldwide, especially for vulnerable populations in remote and conflict settings.”

Takeda’s commitments to these new partners in FY2024 include:

•	**JPY 1,007 million (Approx. USD 7.0 million) to *Population Services International (PSI)*** to expand vaccine access through pharmacy-based immunization across Ethiopia, Kenya and Nigeria, linking pharmacies to national vaccination programs, creating new service points within health systems and reducing the burden on public clinics, ultimately creating a blueprint to scale immunization access across Africa.

•	**JPY 310 million (Approx. USD 2.1 million) to *Bulungula Incubator*** to integrate a community-driven, holistic healthcare approach with the national health system in South Africa’s remote Xhorha Mouth Administrative Area, demonstrating a replicable approach to universal healthcare in rural areas, empowering community health workers, and integrating healthcare across local schools, sports events and community radio.

•	**JPY 1,169 million (Approx. USD 8.1 million) to *Reach Out Cameroon*** to increase access to appropriate care and psychosocial support for women and girls in extremely hard-to-reach communities experiencing long-term conflict in Cameroon, Democratic Republic of Congo and Nigeria by training health workers, supply chain managers and youth champions, and increasing the capacity of 270 poorly equipped health facilities in highly populated communities to offer quality services, supplies and information.

•	**JPY 895 million (Approx. USD 6.2 million) to *Seed Global Health*** to support Malawi, Sierra Leone, Uganda and Zambia in building a skilled health workforce to support their national health goals including launching new academic programs in OB/GYN and neonatal emergency care, establishing three locally led centers of excellence for maternal and neonatal health service training and delivery and graduating 5,900 qualified health professionals ready to serve their communities.

•	**JPY 1,259 million (Approx. USD 8.7 million) to *VillageReach*** to support Democratic Republic of Congo, Guinea, Malawi, Tanzania and Uganda in strengthening the capacity of their national health systems to rapidly and reliably transport patient samples to laboratories for diagnosis and promptly respond to outbreaks, as well as create an integrated solution for all outbreak-prone diseases to contain them faster. As a result, countries will be able to detect diseases early, save lives and reduce the burden on fragile health systems during disruptions.

The new partners shared:

•	 “疫苗 save people’s lives, and amidst global decreases in routine immunizations we see the potential to mobilize pharmacies to provide vaccines – all at scale,” said Karl Hofmann, CEO and president, PSI. “This partnership will support health systems to increase vaccination rates, equip people to take charge of their health, and accelerate our collective progress toward Universal Health Coverage.” 

•	 “We are honored to partner with Takeda to significantly enhance healthcare access and outcomes in remote rural communities, ensuring sustainable, community-driven health solutions,” said Réjane Woodroffe, director, Bulungula Incubator. “By enclosing the circle of compassion and care, we are committed to including those most often left behind. Together, we aim to create resilient communities where every individual has the opportunity to thrive.” 

•	 “At a time when the world is facing severe challenges from humanitarian emergencies, especially conflict-driven emergencies, access to quality care is the right of every woman and girl,” said Esther Omam Njomo, executive director, Reach Out Cameroon. “Our partnership with Takeda is a bold step towards improving that access for women and girls in conflict-affected communities in Cameroon, DR Congo and Nigeria.”

•	 “Takeda’s generous support allows Seed Global Health and our local partners to train more doctors, nurses, and midwives and provide them with the resources they need to deliver high quality care and save lives,” said Andrew Musoke, COO, Seed Global Health. 

•	 “With a rise in emerging outbreaks, the need for responsive primary health care systems is more urgent than ever,” said Emily Bancroft, CEO and president, VillageReach. “This partnership with Takeda offers a timely opportunity to work with governments to bolster the infrastructure that allows them to detect and contain outbreaks quickly. By speeding up identification and diagnosis, we can enable swift response to extreme epidemics and save countless lives.”

 Since its launch in 2016, Takeda’s Global CSR Program has reached more than 17.8 million direct beneficiaries in 93 countries and contributed to strengthening health systems including the following areas informed by WHO’s Health System Strengthening Building Blocks:

•	**Accelerating Service Delivery and Access to Essential Medicines:** Improved accessibility, coverage and quality of service delivery (e.g., screening, referrals and follow ups) for more than 13.4 million people; provided essential health supplies to more than 28,000 people; empowered more than 4.1 million community members with targeted health education, including on nutrition, water, sanitation, hygiene, and sexual and reproductive health; and refurbished or built over 2,700 health facilities.

•	**Empowering the Health Workforce:** Developed knowledge, skills, motivation and deployment of health workforce by providing training to more than 110,000 qualified health professionals and community health workers responsible for organizing and delivering health services, as well as those who do not deliver services directly but are essential to the performance of health systems, such as health supply chain managers and health information system administrators.

•	**Advancing Health Information Systems:** Developed, enhanced, or implemented 276 digital solutions, platforms, or tools to support data-informed health planning and health decision-making.

•	**Strengthening 领导 and Governance:** Developed or enhanced 420 strategic plans and policies linked to national and local needs and priorities to ensure local ownership while sustaining and scaling innovative solutions.

## 关于 Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R\&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, 我们的人民和地球. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit [c.um-care.com](http://c.um-care.com).

## Media Contacts:

<media_relations@um-care.com>

## Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.
The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

## Forward-Looking 语句

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which
could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: <http://c.um-care.com/investors/sec-filings-and-security-reports/> or at [www.sec.gov](http://www.sec.gov). Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

## Exchange Rates

In this press release certain amounts presented in Japanese yen have been translated to US dollars solely for the convenience of the reader. Except where otherwise noted, these convenience translations have been made at an exchange rate of 1USD = 144.86 JPY, the Noon Buying Rate certified by the Federal Reserve Bank of New York on August 23, 2024. The rate and methodologies used for these convenience translations differ from the currency exchange rates and translation methodologies under IFRS used for the preparation of Takeda’s consolidated financial statements. These translations should not be construed as a representation that the relevant Japanese yen amounts could be converted into U.S. dollars at this or any other rate.

OSAKA, Japan and CAMBRIDGE, Massachusetts, 2024年9月18日 – Takeda (TSE:4502/NYSE: TAK) today committed JPY4.6 billion (Approx. USD 32 million) to five new Global Corporate Social Responsibility (CSR) partners as part of the company’s ongoing commitment to improving health systems resiliency in low and middle-income countries around the world. This commitment demonstrates Takeda’s focus on tackling systemic disparities and supporting local leadership in strengthening health infrastructure, empowering health workforce, and increasing local knowledge and capacity to improve equitable and sustainable healthcare access and delivery. 

Takeda Commits Over $32 Million in Five New Global Corporate Social Responsibility Partnerships  To Further Drive Health Impact in 93 Countries

* ***cTTP is an Ultra-rare, Potentially Fatal Blood-Clotting Disorder with Limited Treatment Options; Untreated, Acute TTP Events Have a Mortality Rate of >90%1,2***
* ***Approval Based on Totality of Evidence, Including Results from the First Randomized, Controlled, Open-label, Crossover Phase 3 cTTP Trial***
 

**OSAKA, Japan and CAMBRIDGE, Massachusetts, 2024年8月7日** – Takeda ([TSE:4502/NYSE:TAK](http://c.um-care.com/investors/overview/)) today announced that the European Commission (EC) approved ADZYNMA®▼ (recombinant ADAMTS13) for the treatment of ADAMTS13 deficiency in children and adult patients with congenital thrombotic thrombocytopenic purpura (cTTP).3 ADZYNMA is now the first and only enzyme replacement therapy in the European Union (EU) specifically for the treatment of cTTP.3,4 This approval includes confirmation of orphan medicinal product designation and follows a positive opinion from the Committee for Medicinal 产品 for Human Use, as [announced](http://c.um-care.com/newsroom/newsreleases/2024/positive-chmp-opinion-for-adamts13-in-cttp/) by the company on May 31, 2024. 

cTTP is an ultra-rare, chronic blood clotting disorder caused by a deficiency in the ADAMTS13 enzyme.1 It is associated with acute events and debilitating chronic symptoms or thrombotic thrombocytopenic purpura (TTP) manifestations, which can include thrombocytopenia, microangiopathic hemolytic anemia, renal manifestations, stroke and abdominal pain.1,2,5 If left untreated, acute TTP events have a mortality rate of >90%.1,2

“A century after the scientific discovery of cTTP, significant unmet needs remain for patients who continue to face life-threatening acute events and debilitating chronic symptoms with limited treatment options,” said Ricardo Marek, President, Europe and Canada Business Unit at Takeda. “This approval marks the first treatment specifically indicated to address the root cause of the disease – ADAMTS13 deficiency. Building on our 70-year legacy of innovation in rare blood disorders, we’re proud to offer ADZYNMA to cTTP patients in the EU and remain committed to bringing innovative medicines to rare disease patients with high unmet need.”

The EC approval was supported by the totality of evidence provided by the interim analysis of efficacy, pharmacokinetic, safety and tolerability data from the first randomized, controlled open-label, crossover Phase 3 trial in cTTP, as well as safety and efficacy data from the continuation trial. Data from the Phase 3 trial ([NCT03393975](http://clinicaltrials.gov/study/NCT03393975)) were published in The *[New England Journal of Medicine](http://www.nejm.org/doi/full/10.1056/NEJMoa2314793)* in May 2024. 

In the Phase 3 trial, patients received 40 IU/kg ADZYNMA IV or plasma-based therapy every other week or weekly, based on regimen at enrollment for months 1-6 (period 1), crossing over to the alternate treatment for months 7-12 (period 2), and all patients received ADZYNMA for months 13-18 (period 3).3 

No patient experienced an acute TTP event while receiving ADZYNMA prophylactic treatment (n=45), while there was one acute TTP event in a patient receiving plasma-based therapies (n=46).3 One subacute TTP event was reported in one patient receiving ADZYNMA during the controlled comparison periods 1 and 2, compared to seven subacute TTP events in six patients receiving plasma-based therapies.3 In the continuation phase (period 3), efficacy results – incidence rates of acute and subacute TTP events – were consistent with the results from periods 1 and 2.3

ADZYNMA demonstrated a favorable safety profile compared to plasma-based therapies. The most common adverse reactions (incidence >10%) were headache, diarrhea, dizziness, upper respiratory tract infection, nausea and migraine.3

Takeda is investigating recombinant ADAMTS13 in adults with immune-mediated thrombotic thrombocytopenic purpura (iTTP), the acquired form of TTP, in an ongoing Phase 2b trial ([NCT05714969](http://clinicaltrials.gov/study/NCT05714969?cond=iTTP&rank=4)).

This approval does not result in any changes to Takeda’s consolidated forecast for the fiscal year ending March 31, 2025 (FY2024).

## 关于 ADZYNMA 

ADZYNMA (recombinant ADAMTS13) is the first and only recombinant “A disintegrin and metalloproteinase with thrombospondin motifs 13” (ADAMTS13) enzyme replacement therapy approved for the treatment of ADAMTS13 deficiency in children and adult patients with cTTP. ADZYNMA is also approved by the U.S. Food and Drug Administration (FDA) and by the Japanese Ministry of Health, Labour, and Welfare (MHLW) for the prophylactic and on-demand treatment of patients with cTTP.
 
ADZYNMA was granted Orphan Drug Designation (ODD) by the U.S. FDA for the treatment and prevention of TTP, including its acquired idiopathic and secondary forms, as well as Fast Track and Rare Pediatric Disease Designation. The U.S. FDA granted Takeda a Rare Pediatric Disease Voucher for the approval of ADZYNMA. ADZYNMA was also granted ODD by the European Medicines Agency (EMA) and Japanese MHLW for the treatment of TTP.

**For the full list of side effects and restrictions with ADZYNMA, see the [Product Information](http://ec.europa.eu/health/documents/community-register/2024/20240801162985/anx_162985_en.pdf).** 

## 关于 cTTP

cTTP is an ultra-rare, chronic and debilitating clotting disorder associated with life-threatening acute events and debilitating chronic symptoms, or TTP manifestations.6,7 Although the exact prevalence of cTTP is unknown, estimates suggest a prevalence of 0.5-2 diagnosed cases/million.8 It develops due to deficiency in ADAMTS13, a von Willebrand factor (VWF) cleaving protease, which results in the accumulation of ultra-large VWF multimers in the blood.6 The accumulation of ultra-large VWF multimers leads to uncontrolled platelet aggregation and adhesion.5,7 This can lead to abnormal clotting in the small blood vessels of the body and is associated with microangiopathic hemolytic anemia and low platelet levels (thrombocytopenia).5
 
cTTP has both acute and chronic manifestations (including stroke, renal and cardiovascular disease) and when left untreated, acute TTP events have a mortality rate of >90%.1,2,5 cTTP can also cause ongoing widespread organ damage and other co-morbidities resulting from an ADAMTS13-deficient state.2,7,9,10

## 关于 Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, 我们的人民和地球. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit [c.um-care.com](http://c.um-care.com/).

### Media Contacts:

#### Japanese Media

Jun Saito

[jun.saito@um-care.com](mailto:jun.saito@um-care.com)
 
#### U.S. and International Media

Megan Ostrower

[megan.ostrower@um-care.com](mailto:megan.ostrower@um-care.com)
 
## Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.
 
The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies. 
 
## Forward-Looking 语句

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: [http://c.um-care.com/investors/sec-filings-and-security-reports/](http://c.um-care.com/investors/sec-filings-and-security-reports/) or at [http://www.sec.gov/](http://www.sec.gov/). Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.
 
## Medical Information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

ADZYNMA is a registered trademark of Takeda Pharmaceuticals International AG.

## References:

1. Van Dorland H et al. Haematologica. 2019;104:2107-16.
2. Joly BS et al. Blood. 2017;129(21):2836–2846.
3. ADZYNMA (recombinant ADAMTS13) Summary of Product Characteristics; 2024. 
4. Scully M et al. Blood. 2017; 130:2055-63.
5. Chiasakul T and Cuker A. Am Soc Hematol. 2018;2018(1):530–538.
6. Alwan F et al. Blood. 2019;133:1644-51.
7. Kremer Hovinga JA et al. Nat Rev Dis Primers. 2017;3:17020.
8. Kremer Hovinga JA and George JN. Hereditary Thrombotic Thrombocytopenic Purpura. N Engl J Med. 2019;381(17):1653-1662.
9. Zheng XL et al. J Thromb Haemost. 2020;18(10):2486-95.
10. Sukumar S et al. J Clin Med. 2021;10:536.

Takeda announces EC approval for ADZYNMA® (recombinant ADAMTS13), the first enzyme replacement therapy for congenital thrombotic thrombocytopenic purpura (cTTP), addressing a critical unmet need in rare blood disorders.

欧洲委员会批准&#21313;&#22823;&#32593;&#36172;&#24179;&#21488;ADZYNMA®▼(重组ADAMTS13)作为首个也是唯一一个用于先天性血栓性血小板减少性紫癜(cTTP)的重组ADAMTS13替代疗法

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