Takeda Pharmaceutical Commits to Advancing Next-Generation Biotechnology to Drive High-Quality Development of China's Biopharmaceutical Industry

SHANGHAI, Oct. 21, 2021 /PRNewswire/ -- Takeda Pharmaceutical Company Limited grandly held the inauguration ceremony for its new China Regional Headquarters and Takeda Asia Development Center at the Expo Qiantan area, demonstrating through concrete actions its long-standing commitment to establishing deep roots in Shanghai, leveraging its role as a global biopharmaceutical company to support the development of the biopharmaceutical industry, and enhancing Chinese patients' access to innovative medicines. Zhu Yi, Deputy Director of the Shanghai Municipal Commission of Commerce; Shi Yinghua, Deputy Director of the Expo Administration Bureau of the China (Shanghai) Pilot Free Trade Zone Management Committee; Cao Lei, Deputy Director of the Pudong New Area Commission of Commerce; and Du Yanying, Party Group Member of the Bonded Zone Administration Bureau of the China (Shanghai) Pilot Free Trade Zone Management Committee and Director of the Waigaoqiao Office, along with nearly 30 guests from universities, business associations, and the pharmaceutical industry, including Fudan University, the Shanghai Association of Foreign Investment, Fidelity Investments, and LYFE Capital, jointly attended the event. On the same day, Takeda hosted a roundtable discussion themed "Innovation and Integration: Deepening the High-Quality Development of Shanghai's Biomedical Industry Cluster," inviting representatives from industrial promotion agencies, intellectual property sectors, R&D, investment capital, and patient organizations to explore how to address Chinese patients' needs for innovative healthcare. The discussion focused on leveraging Shanghai's high-quality development in optimizing policy environments, innovating service systems, and building talent hubs to drive a higher-level upgrade of the entire industrial ecosystem.

Inauguration Ceremony for the New Location of Takeda China Regional Headquarters and Takeda Asia Development Center

Mr. Shan Guohong, President of Takeda China, stated: "As Takeda advances its global expansion strategy, China has consistently remained one of our key strategic markets. We are deeply honored to establish our regional headquarters in Shanghai's Expo Qiantan area on the occasion of Takeda’s 240th anniversary, marking another significant milestone in our development in China. Looking ahead, we will leverage the momentum of Pudong's high-quality opening-up, draw upon our innovative capabilities and global expertise, and continue to accelerate the introduction of innovative products and technologies, contributing to Shanghai's endeavor to build a world-class biopharmaceutical industry cluster."

Remarks by Mr. Shan Guohong, Senior Vice President, Global, and President, Takeda China, Takeda Pharmaceutical Company Limited

Rooted in Chinese PatientsPositioning for Next-Generation Biotechnology

China's pharmaceutical market is undergoing an innovation-driven industry transformation, with biomedicine serving as one of Shanghai's three leading industries representing the nation in global competition.^[1]. Shanghai is actively developing a world-class biopharmaceutical industry cluster and has attracted numerous competitive, innovative biopharma enterprises, which will facilitate the realization of Shanghai’s strategic goals. Following the inaugural Shanghai International Biopharma Industry Week, Takeda has once again convened representatives from industry, R&D, investment, intellectual property, and patient organizations. Focusing on critical segments of the biopharma industry ecosystem, the gathering aims to foster synergistic integration and co-development to leverage sector-specific advantages, thereby driving a higher-tier upgrade of the entire industrial ecosystem. Takeda Pharmaceutical Company Limited emphasizes that as the biopharmaceutical cluster develops, pharmaceutical enterprises must maintain a patient-centric focus, addressing unmet medical needs through clinical-value-driven innovation. Takeda has affirmed its commitment to partnering with domestic stakeholders and ecosystem collaborators to integrate Chinese innovation into the global innovation system.

“We believe that over the next 10 to 20 years, China will become one of the global hubs for biopharmaceutical innovation,” Mr. Shan Guohong said. “With the accelerated introduction to China of our 15 innovative medicines and the first wave of our global R&D pipeline poised for peak value conversion, we hope to leverage Takeda’s innovative capabilities and international experience to support the high-quality development of China’s biopharmaceutical industry and integrate into the development of China’s biopharmaceutical innovation ecosystem.”

Biopharmaceutical companies, represented by Takeda, are firmly confident in Shanghai's development and future potential. As early as 2012, Takeda established its China Regional Headquarters and Asia Development Center in Shanghai. Starting in 2015, the company cumulatively invested RMB 1.5 billion over a five-year period, specifically to support new drug development in China. In 2017, the Takeda Asia Development Center was upgraded to become one of the company's four key global development hubs. Since 2018, the Asia Development Center has accelerated its integration into the global R&D network. By incorporating China into the early phases of drug development, Takeda has progressively achieved simultaneous development of all its new drugs in China and globally.

With a sound and well-developed biopharmaceutical industrial system, highly concentrated R&D resources, and leading innovation capabilities, Shanghai has also attracted numerous outstanding foreign-invested biopharmaceutical enterprises. According to statistics, 18 of the top 20 global pharmaceutical companies and 17 of the top 20 medical device companies have already established operations in Shanghai, actively setting up their China regional headquarters and R&D centers.^[2]。

Showcasing China Speed, Empowering Global Innovation

2021 is a pivotal year for Takeda, as the R&D pipeline enters a critical phase for the first global wave of value realization. Currently, 5 to 6 new molecular entity (NME) drugs have been submitted to the U.S. Food and Drug Administration (FDA) for regulatory review. Among them, mobocertinib, an innovative therapy for lung cancer, received FDA approval this September.^[3]. Meanwhile, Takeda is actively expanding its R&D pipeline for a second wave of value-realization peaks, currently comprising approximately 30 new molecular entities in early clinical development.

China serves as one of the key engines driving Takeda's global R&D. The Asian Development Center in Shanghai is actively committed to accelerating the development of innovative drugs, empowering global innovation with "China speed." As a breakthrough achievement in global simultaneous drug development, the innovative lung cancer therapeutic mobocertinib marks the first instance of simultaneous submission of marketing authorization applications in China and globally.^[4]。Mobocertinib is the world's first, and currently the only dedicatedAn oral therapy specifically targeting patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutation-positive non-small cell lung cancer (NSCLC). Mobocertinib was formally accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in July 2021 and was approved for inclusion in the priority review and approval process.^[5], expected to be approved next year.

Dr. Wang Lin, Head of Takeda's Asia Development Center, stated: “We are committed to accelerating the introduction of truly innovative and breakthrough therapies to China through our global simultaneous new drug development program. We will introduce more than 15 highly innovative drugs within five years, enabling Chinese patients to access innovative therapies simultaneously with the global market.”

Dr. Wang Lin, Head of Takeda Asia Development Center, participated in the panel discussion.

In addition to a robust R&D pipeline, Takeda is actively advancing next-generation biotechnology globally and collaborating with world-leading academic and medical institutions. Striving to become a leader in cell and gene therapy, the company aims to deliver transformative or curative treatments to specific patient populations to address unmet medical needs. This year, Takeda announced the acquisition of Maverick Therapeutics to strengthen its pipeline in T-cell therapies for solid tumors and cancer immunotherapy.

On the day of the event, Takeda Pharmaceutical Company Limited also announced that icatibant acetate injection, indicated for the treatment of acute attacks of hereditary angioedema (HAE), has completed all import procedures and regulatory drug testing. It has recently become commercially available and is now ready to support clinical experts who have long been managing HAE, ultimately benefiting a wider patient population. The commercial availability of icatibant acetate injection will enable timely intervention for acute HAE attacks, preventing the life-threatening risk of asphyxiation due to laryngeal edema and alleviating the physical and psychological distress caused by edema in other anatomical sites. As one of the first batch of clinically urgently needed overseas new drugs,^[6]Icatibant acetate injection was approved in April 2021.^[6]，Priority review and approval has previously been granted.

At the upcomingAt the 4th China International Import Expo, Takeda will showcase its innovative products and breakthrough therapies in oncology, gastroenterology, rare diseases, neuroscience, and plasma-derived therapies. The novel lung cancer drug mobocertinib and icatibant acetate injection for the treatment of acute hereditary angioedema (HAE) attacks will also be prominently featured at Takeda's booth.

Declaration:

1. This article is intended to convey cutting-edge medical and pharmaceutical information and does not constitute a recommendation or promotion of any drug or treatment regimen.

2. For more information on diseases, medicines, or diagnosis and treatment, please consult a healthcare professional.

^[1]Shanghai Municipal People's Government: Shanghai Releases Catalog of Urgently Needed Talent Development in Scientific and Technological Innovation, to Accelerate Talent Team Building in Three Leading Industries
https://www.shanghai.gov.cn/nw15343/20210915/aef475507d15444b96eabcb90e1ed781.html

^[2]Xinhua News Agency: Bringing More Innovative and High-Quality Medicines to Benefit Humanity -- Observations from the 2021 Shanghai International Biomedical Industry Weekhttp://news.21cn.com/caiji/roll1/a/2021/1014/19/49432254.shtml

^[3]Takeda's Innovative Lung Cancer Drug Mobocertinib Receives U.S. Food and Drug Administration (FDA) Approvalhttps://www.takeda.com.cn/news-room/news-releases/2021/mobocertinibfda/

^[4]Takeda's Marketing Authorization Application for Class 1 Innovative Lung Cancer Drug Mobocertinib (TAK-788) Officially Accepted in Chinahttps://www.takeda.com.cn/news-room/news-releases/2021/mobocertinib-tak-788-/

^[5]Takeda’s Icatibant Acetate Injection Approved for Acute Attacks of Hereditary Angioedema Safeguarding the Lives of HAE Patients in Chinahttps://www.takeda.com.cn/news-room/news-releases/2021/-hae/

^[6]List of Clinically Urgently Needed Overseas New Drugs (First Batch). CDE. 2018.https://www.cde.org.cn/main/news/viewInfoCommon/21de8acd6c395746b041b2ad93eb5c43