-
GRIT Biotechnology’s GT201 TIL Therapy Approved for Clinical Studies by China’s CDE
•
The Center for Drug Evaluation (CDE) website has indicated that GRIT Biotechnology, a China-based cell therapy specialist, has received approval for its in-house developed gene engineered tumor-infiltrating lymphocyte (TIL) therapy, GT201, for clinical studies in patients with recurrent or metastatic solid tumors. Optimal Structural Design and Custom Retroviral System for…
-
Novartis Terminates TIGIT-Targeted Antibody Deal with BeiGene, Retains Rights to Ociperlimab
•
Swiss pharmaceutical giant Novartis AG (NYSE: NVS) has decided to terminate an option and license deal with China-based BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235), which was focused on the development of BeiGene’s TIGIT-targeted antibody drug, ociperlimab. The initial deal, signed in December 2021, included a USD 300 million upfront…
-
Biocytogen Pharmaceuticals Awarded CNIPA Patent for RenMab Human Antibody Mice Platform
•
Biocytogen Pharmaceuticals (Beijing) Co., Ltd (HKG: 2315), a China-based biopharmaceutical company, has announced receiving a patent award from the China National Intellectual Property Administration (CNIPA) for its in-house developed human antibody mice RenMab platform. The patent, titled “Genetically modified non-human animals with humanized immunoglobulin loci”, is valid through February 18,…
-
Guangdong’s OptoMedic Secures Over $27.8 Million in Pre-IPO Financing for Endoscopy Innovations
•
OptoMedic Technologies, Inc., a leading endoscopy specialist based in Guangdong, has reportedly raised upwards of RMB 200 million (USD 27.8 million) in a pre-IPO financing round. The round was led by CCB Private Equity Investment and Huajin Capital, with participation from Guoxin Capital and Befor Capital. The funds will be…
-
Jiangsu Hengrui Pharmaceuticals’ Irinotecan and Bupivacaine Liposome Injections Get Clinical Trial Green Light in China
•
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a China-based pharmaceutical company, has announced receiving separate clinical trial approvals in China for its irinotecan liposome injection and bupivacaine liposome injection. These approvals mark a significant step forward in the development of these targeted therapies. Irinotecan Liposome Injection for Advanced Colorectal Cancer…
-
Shanghai Junshi Biosciences’ Tuoyi Files for 9th Indication in China for RCC Treatment
•
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the National Medical Products Administration (NMPA) has accepted for review an additional indication approval filing for its Tuoyi (toripalimab), a programmed death-1 (PD-1) inhibitor, in combination with axitinib for first-line unresectable or metastatic renal cell carcinoma (RCC). This…
-
Jiangsu Hengrui Pharmaceuticals Receives Clinical Trial Approvals for Irinotecan and Bupivacaine Liposome Injections
•
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a China-based pharmaceutical company, has announced receiving separate clinical trial approvals in China for its irinotecan liposome injection and bupivacaine liposome injection. These approvals mark significant steps in advancing the company’s pipeline in oncology and pain management. Irinotecan Liposome Injection for Advanced Colorectal…
-
Shanghai Junshi Biosciences’ Tuoyi Files for 9th Indication in China for RCC Treatment
•
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the National Medical Products Administration (NMPA) has accepted for review an additional indication approval filing for its Tuoyi (toripalimab), a programmed death-1 (PD-1) inhibitor, in combination with axitinib for first-line unresectable or metastatic renal cell carcinoma (RCC). This…
-
Ji Xing Pharmaceuticals and TSH Biopharm Announce Collaboration for Dry Eye Treatment in Taiwan
•
Shanghai-based Ji Xing Pharmaceuticals, a company backed by RTW Investments, has announced a strategic collaboration agreement with Taiwan-headquartered TSH Biopharm (TSH). Under this agreement, TSH will provide commercialization support for varenicline solution nasal spray (US brand name Tyrvaya) in Taiwan. The financial details of the collaboration were not disclosed. Varenicline…
-
Hrain Biotechnology’s Anti-CD70 T Cell Therapy HR010 Gets Tacit Approval for Renal Cancer Trial
•
Shanghai-based Hrain Biotechnology Co., Ltd. has announced receiving tacit clinical trial approval from the Center for Drug Evaluation (CDE) for its anti-CD70 T cell therapy, HR010. The therapy is intended for the treatment of advanced or metastatic renal cancer. CD70 as a Potential Target for Kidney Cancer TreatmentCD70, a member…
-
Huadong Medicine’s Elahere Receives Approval for FRα Positive Cancer Treatment in China
•
China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced receiving approval to introduce Elahere (mirvetuximab soravtansine), an antibody drug conjugate (ADC) targeting folate receptor α (FRα), at Ruijin Hospital’s Hainan branch. The treatment is indicated for FRα positive, platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in…
-
WuXi Biologics Proposes Spin-Off and Listing of WuXi XDC on Hong Kong Stock Exchange
•
China-based Contract Research, Development, and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) has announced the proposed spin-off and separate listing of its subsidiary, WuXi XDC Cayman Inc. (WuXi XDC, HKG: 2268), on the Hong Kong Stock Exchange’s Main Board. WuXi XDC’s Specialized Services in Bioconjugates and ADCsWuXi XDC, a joint…
-
Jiangxi Jemincare Group Launches Omalizumab Biosimilar CMAB007 in China for Asthma and Dermatology
•
Jiangxi Jemincare Group has overseen the official launch and first prescription of its omalizumab biosimilar, CMAB007, a version of Roche/Genentech’s (SWX: ROG) anti-IgE dermatology and asthma therapy Xolair, in Beijing. The drug’s launch comes less than two months after it received market approval. Therapeutic Applications of OmalizumabOmalizumab is utilized to…
-
Zhejiang Doer Biologics Partners with BioNTech for Global Development of Innovative Biological Drugs
•
Zhejiang Doer Biologics Co., Ltd, a China-based clinical-stage biopharmaceutical company, has announced a significant licensing agreement with Germany’s BioNTech SE (NASDAQ: BNTX). Under the terms of this deal, Doer Bio will provide BioNTech with a global license to research, develop, manufacture, and commercialize innovative biological drugs targeting an undisclosed therapeutic…
-
C4 Therapeutics’ CFT8919 Earns FDA Approval for Clinical Trials Targeting EGFR L858R Mutations
•
US-based C4 Therapeutics Inc., (NASDAQ: CCCC) has announced receiving clinical trial approval from the US FDA for its pipeline candidate, CFT8919. This orally bioavailable BiDAC degrader is designed to target EGFR L858R mutations and has demonstrated good activity and selectivity against solid tumors carrying these mutations. Pre-Clinical Success and Potential…
-
Zai Lab’s Vyvgart Receives NMPA Review for Subcutaneous Injection Form in gMG Treatment
•
China-based Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) has announced that the National Medical Products Administration (NMPA) has accepted for review a Biologics License Application (BLA) for Vyvgart (efgartigimod alfa) in subcutaneous injection form. The intended indication is for adult patients with generalized myasthenia gravis (gMG). Exclusive Rights and Prior…
-
Sino Medical Sciences Receives Approval for Next-Generation Drug-Eluting Stent in Indonesia
•
China-based Sino Medical Sciences Technology Inc., (SHA: 688108) has announced receiving market approval for its next-generation drug-eluting stent system, BuMA Supreme, in Indonesia. The product is approved for use in improving the symptoms of vascular stenosis and will be eligible for marketing until October 19, 2027. Composition and Design of…
-
Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for HRS-9815 Radiodiagnostic Drug Clinical Study
•
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a China-based pharmaceutical company, has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its injectable HRS-9815 and the accompanying preparatory kit. The product candidate is an in-house developed Category 1 radiodiagnostic drug. HRS-9815: A Radiodiagnostic…
-
Everest Medicines and Sinopharm Group Ink MoU to Enhance Distribution and Collaboration
•
China-based Everest Medicines (HKG: 1952) has announced the signing of a memorandum of understanding (MoU) with Sinopharm Group Co., Ltd. The partnership aims to capitalize on Sinopharm’s supply chain service advantages in distribution, access, and retailing for Everest’s listed products within mainland China. The collaboration will also explore new product…
