The U.S. FDA granted breakthrough therapy designation to Abbisko Therapeutics Co. Ltd.’s pimicotinib for patients with tenosynovial giant cell tumors who are not able to have surgery.
ABVC Biopharma Inc is headquartered in San Francisco but it has its roots in Taiwan where it is digging into traditional medicine and validating it for the modern world. “There are a number of drugs that can’t be synthesized in the lab,” ABVC CEO Howard Doong told BioWorld, so he is going back to the original source of traditional Chinese medicines to validate them using traditional drug development models.
Chinese firm Hutchmed Ltd. has out licensed its targeted colorectal cancer drug fruquintinib to Takeda Pharmaceutical Co. Ltd. as it eyes growth opportunities in the U.S., Europe and Japan in a deal totaling up to $1.13 billion. Under the terms of the agreement, Tokyo, Japan-based Takeda will gain an exclusive worldwide license to develop and commercialize the drug in all indications and territories outside of mainland China, Hong Kong and Macau.
Hadasit Medical Research Services and Development Ltd. and BIRAD – Research & Development Company Ltd. have inked a development deal with Immix Biopharma Inc. for tissue specific therapeutics based on their jointly developed anti-B-cell maturation antigen CAR T cells targeting plasma cell technology.
Baili Biopharmaceutical Co. Ltd. has raised ¥990.47 million (US$146 million) on the Shanghai STAR Market. Its shares opened Jan. 6 at ¥28.75 apiece, surging over 30% its first trading day, and closing at ¥38.40 on Jan.9.
Wuxi Biologics (Cayman) Inc. is providing an exclusive license to GSK plc for a preclinical bispecific T-cell engaging antibody along with the option of three additional bi- and multispecific TCE antibodies developed by Wuxi. In exchange, Wuxi will receive an up-front payment of $40 million and up to $1.46 billion in additional payments for research, development, regulatory and commercial milestones across the four TCE antibodies. Wuxi Biologics, of Shanghai, is also eligible to receive tiered royalties on net sales.
Sciclone Pharmaceuticals Holdings Ltd. has obtained marketing approval in China for Danyelza (naxitamab) for patients with relapsed or refractory high-risk neuroblastoma. The drug, in combination with granulocyte macrophage colony-stimulating factor, was approved to treat pediatric patients aged 1 and above, as well as adults, who have relapsed or refractory high-risk neuroblastoma in the bone or bone marrow and have demonstrated a partial or minor response to prior therapy or stable disease.
Two deals for antibody-drug conjugates inked since May between Merck & Co. Inc. and Sichuan Kelun-Biotech Pharmaceutical Co. Ltd. have blossomed eight months later into the year’s biggest agreement, one that could bring Kelun-Biotech up to $9.3 billion in development, regulatory and sales milestones. The exclusive license and collaboration deal has Merck paying an up-front $175 million to Kelun-Biotech plus promising to make an equity investment in the Sichuan, China-based company.
3D Medicines Inc. has raised HK$408 million (US$52.5 million) in a listing on the Hong Kong Stock Exchange. Its shares opened at HK$29 apiece, jumped by more than 20% by the middle of the day, and closed at HK$31.45 on the first trading day of Dec. 15.
Astellas Pharma Inc. reported top-line results showing zolbetuximab, a monoclonal antibody targeting Claudin 18.2, met the primary endpoint for progression-free survival as well as secondary endpoints for overall survival in the phase III Glow trial in CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
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