-
CStone Pharmaceuticals Publishes Ayvakit Study Results on Oncologist Website
•
China-based CStone Pharmaceuticals (HKG: 2616) has published the results of the China-based bridging NAVIGATOR study for its Ayvakit (avapritinib), a tyrosine kinase inhibitor used to treat gastrointestinal stromal tumors (GIST), on the Oncologist website. The open-label, multi-center Phase I/II study was designed to assess the safety, pharmacokinetics, and anti-tumor efficacy…
-
Biosion Completes Series B Financing Round Led by Guangfa Xinde Investment
•
Biosion, a global, clinical-stage biotech committed to developing antibody-based therapies targeting immune and oncologic diseases, has announced the completion of a Series B financing round at upwards of RMB 100 million (USD 14.33 million). The funding was led by Guangfa Xinde Investment, with contributions from FangFund, Addor Capital, and Suxin…
-
BGI Genomics Receives ANVISA Approval for Colorectal Cancer Detection Kit
•
China-based genomics giant BGI Genomics Co., Ltd (SHE: 300676) has reported receiving product approval from Brazil’s National Health Surveillance Agency (ANVISA) for its colorectal cancer (CRC) early detection real-time PCR product. The diagnostic kit, used for the auxiliary diagnosis of CRC, is a non-invasive product that detects human genes SDC2,…
-
InflaRx and Staidson Amend Deal to Advance Vilobelimab Regulatory Filing in China
•
Germany-based biopharma InflaRx N.V. (Nasdaq: IFRX) has revealed an amendment to its underlying deal with China-based Staidson BioPharma Inc. (STS) to push forward a regulatory filing in China for the anti-C5a antibody vilobelimab (BDB-001). InflaRx will supply Staidson with an exclusive license to access the German firm’s clinical, manufacturing, and…
-
Elpiscience Receives IND Approval for ES014 in China
•
Shanghai-based Elpiscience Biopharmaceuticals Inc. has announced receiving Investigational New Drug (IND) approval in China to initiate a Phase I clinical trial for its bispecific antibody (BsAb) ES014 in patients with advanced solid tumors. ES014 is a potential first-in-class anti-CD39 x TGF-beta immunotherapeutic designed to activate T cells and overcome resistance…
-
Ablaze Pharma and Yonghe Partner for Targeted Radiotherapy Development
•
China-based Ablaze Pharma and Yonghe Pharmaceutical have struck a partnership agreement for the research and development (R&D) and commissioned manufacturing of targeted radiotherapy (TRT). Yonghe, Ablaze’s Contract Development and Manufacturing Organization (CDMO) partner, will provide R&D and cGMP-compliant manufacturing services from the pre-clinical to clinical stages. Company Background and Partnership…
-
InnoCare Pharma’s Orelabrutinib Placed on Partial Clinical Hold by FDA
•
China-based InnoCare Pharma (HKG: 9969, SHA: 688428) has announced that the US FDA has placed orelabrutinib for use in multiple sclerosis (MS) on partial clinical hold. As a result, new enrollment of the Phase II study in the United States will not be initiated. Participants in the US who have…
-
Hainan Poly Pharm Receives FDA Approval for Generic Lincomycin
•
China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced receiving marketing approval from the US FDA for its generic version of US-based Upjohn’s lincomycin. This approval marks a significant milestone for Poly Pharm in expanding its presence in the US market. Drug Profile and IndicationsLincomycin, first approved in the…
