Takeda Unveils Two Innovative Lung Cancer Therapies at CIIE, Marking Entry into China's Lung Cancer Market

Shanghai, November 9, 2021 /PR Newswire/ --November 7, 2021, Takeda Pharmaceutical Company LimitedTakeda Hosts "Double Stars Shining, Wu Expanding New Life" Lung Cancer Special Conference: Mobocertinib and Brigatinib, Known as the "Lung Cancer Double Stars," Debut at CIIE, Marking Takeda Pharmaceutical's Entry into China’s Lung Cancer Treatment Field

Illustration: Guests jointly witness the debut of Takeda's "Lung Cancer Dual Stars"

Lung cancer ranks first in the incidence of malignant tumors in China.^[1], one of the major challenges faced by China in cancer prevention and treatment. In recent years, thanks to the rapid development of medical technology, the survival of lung cancer patients has greatly improved. However, the existing treatment options have limitations for some patients in clinical practice. The survival status of patients with certain rare mutations and refractory types remains unfavorable, urgently requiring more effective solutions. At this year's CIIE, Takeda made its debut with two globally innovative products in the field of lung cancer treatment, officially announcing its entry into the lung cancer sector in China. These two products provide innovative treatment options targeting some rare mutations in lung cancer, offering hope to fulfill the significant unmet needs of these patients.

For example, patients with EGFR exon 20 insertion mutations account for only 2.3% of the total number of non-small cell lung cancer patients.^[2], and currently, there is a lack of targeted treatment options for this mutation target in China, causing these patients to continue with traditional treatments that have limited efficacy. Their prognosis is far worse compared to patients carrying other EGFR mutations. To meet the actual clinical needs of these patients, Mobocertinib, introduced by Takeda for the treatment of non-small cell lung cancer with EGFR exon 20 insertion mutations, has been officially accepted by the Center for Drug Evaluation of the National Medical Products Administration in China and has been approved for inclusion in the priority review and approval process. It is expected to become the first orally administered drug approved in China for the treatment of patients positive for EGFR exon 20 insertion mutations. Mobocertinib, which involved China in global development, has received "SuddenBreaking Therapy Recognition"Definition", and it was approved for marketing by the U.S. FDA in September 2021.

Another group of patients with ALK fusion positivity often face the issue of brain metastases, with nearly 30% presenting brain metastases at initial diagnosis, and during the treatment process, the proportion of intracranial progression is as high as 70%.^[3], seriously affecting the life quality and long-term survival of patients. Since August this year, brigatinib, the second-generation highly selective tyrosine kinase inhibitor (TKI) from Takeda Pharmaceutical Company Limited, has been expedited for approval and application through the "Pilot First" policy in Boao Lecheng, allowing Chinese patients to access internationally advanced innovative drugs without leaving the country. Brigatinib is intended for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) positive for anaplastic lymphoma kinase (ALK). The product shows significant efficacy in treating ALK-positive advanced NSCLC patients and is urgently needed clinically in China.

Figure: Professor Zhou Caicun introduces the current status of lung cancer diagnosis and treatment in China

Chinese Society of Clinical OncologyProfessor Cai-Cun Zhou, Director of the Oncology Department at Shanghai Pulmonary Hospital, Tongji University, and Chairman of the Non-Small Cell Lung Cancer Expert Committee of the Chinese Society of Clinical Oncology (CSCO), stated:"As a medical professional in the field of lung cancer treatment, I am very pleased to see that more and more innovative treatment options are being expedited to be introduced into China with the support of all parties. This brings new hope to patients with rare lung cancer mutations and helps align the level of lung cancer diagnosis and treatment in China with international standards, driving the development of the industry."

While accelerating the introduction of innovative products, Takeda is also actively committed to promoting the application and popularization of precision diagnosis and treatment for lung cancer. To further advance the concept of precision diagnosis and treatment for lung cancer and improve the diagnostic rate of rare and difficult-to-treat targets in the field of lung cancer, during this lung cancer-focused press conference, Takeda announced that it will sign a cooperation framework agreement with five mainstream testing companies in the industry—Burning Rock Biotech, Amoy Diagnostics, Geneseeq Technology, Genecast Biotechnology, and BGI Group—to jointly establish the Takeda Lung Cancer Diagnosis and Treatment Alliance. This alliance aims to promote the concept of precision medicine, better help patients benefit from "precision medicine," and assist in aligning China's lung cancer diagnosis and treatment technologies with international standards.

Illustration: Inauguration Ceremony of Takeda Lung Cancer Diagnosis and Treatment Alliance

"Honored to share global innovation experiences and achievements through the platform of the 4th CIIE, showcasing Takeda's long-term dedication and accomplishments in core areas such as lung cancer exploration, promoting the development of the healthcare industry."Mr. Guohong Shan, Global Senior Vice President of Takeda Pharmaceutical Company Limited, and President of Takeda ChinaSaid: "The field of oncology is one of Takeda's core therapeutic areas globally. Takeda has accumulated extensive industry experience and innovative capabilities in the field of oncology, and is committed to meeting the unmet needs of cancer patients through innovative cancer treatment solutions. Adhering to the concept of 'patient-first,' Takeda will continue to accelerate the development and introduction of innovative drugs, and through multi-party cooperation, jointly enhance China’s cancer diagnosis and treatment standards, contributing to improving public health and supporting the implementation of the 'Healthy China 2030' goals."

Approval No.: C-ANPROM/CN/788/0013

Approval Date: 2021.11

About Takeda Pharmaceutical Company Limited

Takeda Pharmaceutical Company Limited (Tokyo Stock Exchange Stock Code: 4502)(New York Stock Exchange ticker symbol: TAK) is a global biopharmaceutical company headquartered in Japan, driven by values and innovation in research and development. Takeda is committed to translating scientific advances into highly innovative medicines, safeguarding patients' health and bright futures. Takeda focuses on drug development in four key therapeutic areas: oncology, gastroenterology, neuroscience, and rare diseases, with dedicated investments in plasma-derived therapies and vaccines. We consistently concentrate on the development of highly innovative drugs, creating a robust and diverse pipeline through pioneering new treatment options and strengthening our collaborative R&D capabilities to improve people's lives. Our employees, located across approximately 80 countries and regions, work hand-in-hand with local healthcare partners to bring better health to patients worldwide.

Takeda entered China in 1994. The headquarters of Takeda China is located in Shanghai, and its main business centers in mainland China are located in cities and regions such as Beijing, Shanghai, Tianjin, Guangzhou, and the Hong Kong Special Administrative Region. The company has offices in major cities across China and currently employs over 2,000 people in China. With the development of China's economy and the continuous growth in demand for healthcare, China has become one of Takeda’s most important emerging markets globally.

For more information, please visithttps://www.takeda.com

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[1] https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf

[2] Liu ZF, et al. Clinical characterization of ERBB2 exon 20 insertions and heterogeneity of outcomes responding to afatinib in Chinese lung cancer patients. Onco Targets Ther. 2018;11:7323-7331

[3] Costa DB, et al. Clinical Experience With Crizotinib in Patients With Advanced ALK-Rearranged Non-Small-Cell Lung Cancer and Brain Metastases. J Clin Oncol. 2015;33(17):1881-1888