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On June 14, 2024, Yasheng Pharmaceuticals announced the signing of an exclusive option agreement with Takeda Pharmaceuticals regarding Orebatinib. According to the agreement, Yasheng Pharmaceuticals can receive an option payment of $100 million and will be eligible for up to approximately $1.2 billion in option exercise fees and additional potential milestone payments, as well as a double-digit percentage of annual sales revenue. On July 2nd, Yasheng Pharmaceutical received an option payment of $100 million. It is reported that this is not the first time that Takeda Pharmaceuticals has issued a license in the Chinese innovative drug pipeline. As early as January 2023, Takeda acquired the global equity of Hohhot Pharmaceuticals' furquinib for $1.16 billion,

 

 

 

According to publicly available information, the core variety of orebadinib used for the treatment of chronic myeloid leukemia has been included in the priority evaluation and breakthrough treatment varieties by the New Drug Evaluation Center (CDE) of the National Medical Products Administration, and has been approved in China. It is the first marketed variety of Yasheng Pharmaceutical. This variety has also obtained the US FDA fast track qualification, orphan drug qualification certification, and EU orphan drug qualification certification.

 

 

 

In March 2024, Haihe Pharmaceuticals and Japan Dapeng Pharmaceutical Industry Co., Ltd. (hereinafter referred to as "Dapeng Pharmaceuticals") reached an exclusive licensing agreement for the development, production, and commercialization of Gumetinib tablets (R&D code: SCC244) in Japan and other regions. The drug has been submitted for marketing authorization in Japan by Haihe Pharmaceuticals' wholly-owned subsidiary, Haihe Pharmaceuticals Co., Ltd.

 

 

 

According to the data, Gumetinib tablets are an oral small molecule MET inhibitor independently developed by Haihe Pharmaceuticals, with indications for treating locally advanced or metastatic non-small cell lung cancer with MET14 exon mutation. In June, the drug was officially approved for marketing in Japan.

 

 

 

According to the preclinical research results of the system, Gu Meitenib can selectively and strongly inhibit the activity of c-Met kinase in vitro, and has shown rapid induction of tumor regression in various lung cancer animal models with METex14 mutation and MET gene amplification; Gumetinib has good medicinal properties, stable metabolism in the body, is easy to penetrate the blood-brain barrier, and is safe to tolerate. A global multicenter clinical study (GLORY study) showed that the overall objective response rate (ORR) of patients was 65.8%, with an ORR of 70.5% for newly treated patients and 60.0% for treated patients; The median progression free survival in the overall population is 8.5 months, and the median overall survival in the overall population is 17.3 months, indicating clear efficacy in patients with brain metastases.

 

 

 

It is reported that Japanese pharmaceutical companies that have close cooperation with Chinese innovative drugs are not only Takeda Pharmaceutical and Dapeng Pharmaceutical. In the past 2023, they have all had experience with BD Chinese innovative drugs, including First Three Co, Ansteel, Weicai, and Sino foreign Pharmaceutical.

 

 

 

Industry insiders say that overall, in the current market environment, Japanese pharmaceutical companies are likely to become an important force in China's innovative drug mergers and acquisitions and BD. Another person pointed out that in addition to certain pipelines, the gradually opening cooperation model of China's innovative drug market has also been favored by Japanese pharmaceutical companies. In this cooperation between Takeda and Yasheng, in addition to pipeline trading, Takeda also invested in Yasheng, which will be beneficial for two-way BD.