Beigene Ltd. has formed a partnership with Innorna Co. Ltd. to jointly develop messenger RNA (mRNA)-based therapeutics. Shenzhen, China-based Innorna will get an undisclosed up-front payment and is also eligible to receive additional payments based on development, regulatory and commercial milestones, as well as tiered royalties. Beigene will maintain exclusive global rights to the mRNA candidates co-developed in the deal.
Jiangsu Hengrui Pharmaceuticals Co. Ltd. plans to expand its androgen receptor inhibitor, rezvilutamide, to markets abroad after getting a thumbs up from China’s NMPA for treating metastatic hormone-sensitive prostate cancer patients with high-volume disease burden.
Clarity Pharmaceuticals Ltd. is progressing three of its targeted copper theranostics through the clinic that are based on its sarcophagine technology that securely holds copper isotopes inside a cage-like structure, called a chelator. The SAR technology allows a unique pairing of copper isotopes, copper-64 and copper-67, for both cancer diagnosis and therapy.
Sunshine Guojian Pharmaceutical Co. Ltd. has granted Xiling Lab Pharmaceutical Co. Ltd. global rights to develop and commercialize the trastuzumab biosimilar Cipterbin (inetetamab) for antibody-drug conjugates (ADC) in a ¥1.03 billion (US$153 million) deal.
Immuno-oncology company Imugene Ltd. reported median overall survival for patients receiving HER-Vaxx plus chemotherapy was 13.9 months compared to 8.3 months in patients treated with chemotherapy alone in its phase II study in HER2/neu overexpressing advanced gastric cancer.
Shanghai Henlius Biotech Inc. has inked a deal to acquire greater China rights for two cancer-focused bifunctional sialidase programs from Palleon Pharmaceuticals Inc. In return, Palleon will receive an unspecified up-front payment and is eligible for up to $196.5 million in milestone payments.
As an ever-increasing share of companies seek signs of efficacy for investigational drugs in early stage studies, single-arm trials to confirm those effects and support marketing applications are also becoming more common. Now, China’s Center for Drug Evaluation has released draft guidelines on how single-arm trials can be regulated, used to support the new drug application for cancer drugs, and accelerate oncology drug development.
Akeso Inc. has been given the green light by China’s NMPA for its PD-1/CTLA-4 antibody Kaitanni (cadonilimab), which was approved for the treatment of patients with relapsed or metastatic cervical cancer whose disease has progressed on or after platinum-based chemotherapy.
London-based Invox Pharma Ltd. has announced plans to acquire F-star Therapeutics Inc. for $161 million to build up the presence of its parent company, Sino Biopharm Ltd., outside of China.
Japan’s Ministry of Health, Labour and Welfare has given Otsuka Holdings Co. Ltd. subsidiary Taiho Pharmaceutical Co. Ltd. the green light for its oral heat shock protein 90 (HSP90) inhibitor Jeselhy (pimitespib) to treat gastrointestinal stromal tumors (GIST) that have progressed after chemotherapy. The company will soon commercialize the drug in Japan.
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