Daiichi Sankyo Invests ¥1.1 Billion to Build ADC Manufacturing Facility in Shanghai for Flagship Drug Enhertu

Dec 12, 2024 22:37 CST Updated 22:37

Daiichi-Sankyo

Pharmaceutical R&D Developer

December 11,Daiichi Sankyo Company LimitedIt was announced that approximately 1.1 billion yuan will be invested in Zhangjiang, Shanghai, to build a new production facility for Antibody-Drug Conjugates (ADC). The project, located in the Zhangjiang High-Tech Park in Shanghai, includes production facilities, R&D laboratories, and a quality control center to meet future ADC drug research, production, and quality control needs. The factory is planned to be operational by 2030.

It is reported that this isDaiichi-SankyoThe First ADC Drug Factory Established in China.

The timing of this investment is not coincidental, but rather backed by clear strategic considerations.

On November 28, the National Healthcare Security Administration announced the 2024 new edition of the national medical insurance drug list. Trastuzumab deruxtecan (T-DXd, trade name: ENHERTU®, Chinese brand name: Youhedé®), an innovative antibody-drug conjugate (ADC) developed by Daiichi Sankyo and AstraZeneca, has successfully been included in the medical insurance and will be officially implemented starting from January 1, 2025.

In the news, Daiichi Sankyo stated that in order to cope with the increased volume after the product enters the medical insurance system andEnsure product supply aligns with market launch, the company has decided to build a new Antibody-Drug Conjugate (ADC) production plant in Shanghai.

Trastuzumab deruxtecan is a uniquely designed HER2-targeted ADC that was widely used in breast cancer treatment upon its market introduction, revolutionizing the approach to breast cancer therapy.

August 5 this yearTrastuzumab deruxtecan received conditional approval from the National Medical Products Administration (NMPA) in China for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received two or more prior treatment regimens.

Following October, the fourth indication for trastuzumab deruxtecan, lung cancer, was approved in China as a monotherapy for the treatment of patients with HER2 (ERBB2) activating mutations.Adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have previously received at least one systemic therapy.

Currently, in China, the incidence and mortality rates of stomach cancer and lung cancer are both high.

According to statistics, more than one-third of the global stomach cancer cases occur in China, and about 65% of Chinese patients are already at the middle or late stage at the time of diagnosis. The 5-year survival rate is only 9.4%.Lung cancer is the malignant tumor with the highest incidence and mortality rate in China.More than one-third of global cases are in China.Studies show that approximately 4% of NSCLC patients in China have tumors with HER2 mutations.

Especially in the field of lung cancer, inDaiichi-SankyoBefore Trastuzumab Deruxtecan was approved,No HER2-targeted drugs have been approved for NSCLC treatment in China.。

Due to the lack of targeted treatment options, current treatments mainly consist of chemotherapy, immunotherapy, and anti-angiogenic therapy, which have limited efficacy for HER2-mutant NSCLC.

Trastuzumab deruxtecan, as an ADC, delivers chemotherapy drugs precisely to HER2-positive cancer cells via antibodies, reducing damage to healthy cells and thereby enhancing efficacy and minimizing side effects. In patients with HER2-mutant NSCLC, the objective response rate (ORR) reached 58.3%, demonstrating significant clinical efficacy.

In addition, there isWith the support of medical insurance, the ADC market of Daiichi Sankyo is expected to grow significantly in the future.。

This time, it is a layout for the Chinese market,Global MarketAs early as February this year, Daiichi Sankyo announced that it would invest 1 billion euros (equivalent to 1.07 billion US dollars) to expand its ADC production facility located in Munich, Germany, to meet potential future growth demands.

Currently, the first tier of three ADCs from Daiichi Sankyo's DXd-ADC platform, DS-8201, has already been launched and became the best-selling ADC drug in 2023. The HER3 ADC and Trop2 ADC have successively submitted marketing applications. In terms of late-stage clinical trials and commercialization, DS-8201 and Trop2 ADC are in collaboration with AstraZeneca, while HER3 ADC and two other ADCs are in collaboration with Merck.

· END ·

--Featured Recommendations--