-
FDA Panel Weighs in on Narrowing Use of PD-1 Inhibitors in Stomach and Esophageal Cancers
•
The U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) convened on September 26 to scrutinize the application of PD-1 inhibitors in oncology, particularly focusing on Bristol Myers Squibb’s (NYSE: BMY) Opdivo (nivolumab) and Merck, Sharp & Dohme’s (NYSE: MRK) Keytruda (pembrolizumab). The committee evaluated the risk-benefit profile of these drugs for…
-
Zelgen Biopharmaceuticals Receives NMPA Approval for ZG005 Clinical Trial in Advanced Solid Tumors
•
Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase I/II clinical study for its pipeline drug candidate, ZG005, aimed at treating advanced solid tumors. ZG005 is an…
-
Johnson & Johnson Reportedly Winding Down Cardiovascular and Metabolic Pharma Unit
•
Johnson & Johnson (J&J; NYSE: JNJ), a healthcare giant in the U.S., is reportedly winding down its cardiovascular and metabolic pharmaceutical unit, as reported by Endpoints News. Insiders have indicated that J&J has issued notices to its sales, marketing, and medical affairs teams this week. The company has acknowledged the…
-
Shanghai Haihe Pharmaceutical’s Oral Paclitaxel RMX3001 Wins NMPA Nod for Advanced Gastric Cancer
•
Shanghai Haihe Pharmaceutical Co., Ltd from China and its South Korean partner Daehwa Pharmaceutical have received approval from the National Medical Products Administration (NMPA) for their co-developed paclitaxel oral solution RMX3001. This new drug is intended for use in patients with advanced gastric cancer who have experienced disease progression during…
-
TJ Biopharma and Sanofi Ink Deal for Anti-CD73 Antibody Uliledlimab in Greater China
•
TJ Biopharma, a biopharmaceutical company based in China, has entered into a licensing agreement with the French pharmaceutical giant Sanofi. This agreement grants Sanofi exclusive rights to develop, manufacture, and commercialize TJ Biopharma’s anti-CD73 antibody, uliledlimab (TJD5), in Greater China. As part of the deal, Sanofi will make an upfront…
-
Nona Biosciences Partners with Alkyon Therapeutics to Develop Next-Generation Immunotherapies
•
Nona Biosciences, a subsidiary of HBM Holdings Ltd (HKG: 2142), has entered into a strategic partnership with U.S. biotechnology company Alkyon Therapeutics, Inc. (AlkyonTx). The collaboration aims to develop next-generation immunotherapy and other targeted therapy applications, leveraging Nona’s proprietary Harbour Mice fully human antibody platform. The financial details of the…
-
Junshi Biosciences’ Toripalimab Secures EC Nod for Two Cancer Indications
•
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that it has received two indication approvals from the European Commission (EC) for its PD-1 inhibitor, Loqtorzi (toripalimab). This marks a significant expansion of the drug’s utility in the European Union, where it can now be used in combination…
-
Allist Pharma’s Partner Abbisko Receives NMPA Green Light for NSCLC Drug Trial
•
Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotechnology company, has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for ABK3376, an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). This drug is co-developed with Allist Pharmaceuticals Inc., (SHA: 688578), and is intended…
-
HBOW Bio’s First-in-Class Tumor Imaging Drug NC527-X Receives NMPA Clinical Trial Approval
•
HBOW Bio, a precision oncology company supported by Sherpa Healthcare Partners, has secured clinical trial approval from the National Medical Products Administration (NMPA) for its innovative drug candidate NC527-X. This first-in-class near-infrared fluorescence (NIRF) tumor imaging agent is recognized as the world’s first drug to harness low oxygen pathways for…
-
Antengene’s Xpovio Receives NDA Approval in Thailand for Multiple Myeloma Treatment
•
Antengene Corp., Ltd (HKG: 6996), a biopharmaceutical company based in China, has announced that it has received New Drug Application (NDA) approval in Thailand for its drug Xpovio (selinexor). This approval allows the use of Xpovio in combination with bortezomib and dexamethasone to treat adult patients with relapsed or refractory…
-
Wuhan YZY Biopharma Presents M701 Interim Results at 2024 ESMO Congress for NSCLC-Related Pleural Effusion
•
Wuhan YZY Biopharma Co., Ltd (HKG: 2496), a biopharmaceutical company based in China, has announced the presentation of interim analysis results from a Phase Ib clinical study for its investigational drug M701 at the 2024 European Society of Medical Oncology (ESMO) Congress. M701 is a recombinant anti-EpCAM and CD3 human…
-
Allist Pharmaceuticals’ EGFR Inhibitor AST2303 Approved for Clinical Trial in NSCLC by NMPA
•
Allist Pharmaceuticals Inc. (SHA: 688578), a Shanghai-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its AST2303, an oral small molecule epidermal growth factor (EGFR) inhibitor, for adult patients with advanced non-small cell lung cancer (NSCLC) that carries the…
-
Sanofi’s Sarclisa Secures FDA Approval for First-Line Multiple Myeloma Treatment
•
Sanofi (EPA: SAN; NASDAQ: SNY) has announced that the US Food and Drug Administration (FDA) has granted a third indication for its CD38 antibody Sarclisa (isatuximab) for the treatment of multiple myeloma (MM). The new approval allows for the first-line use of Sarclisa in combination with standard-of-care treatments, specifically bortezomib,…
-
Janssen and Yuhan Halt Development of Next-Gen EGFR Inhibitor for NSCLC
•
Yuhan, a South Korean pharmaceutical company, and its partner Janssen Biotech, a subsidiary of US healthcare giant Johnson & Johnson (J&J; NYSE: JNJ), have reportedly decided to halt the development of a next-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) for non-small cell lung cancer (NSCLC). This strategic…
-
Sichuan Biokin’s Multi-Specific Antibody GNC-077 Gets NMPA Nod for Advanced Solid Tumor Clinical Trial
•
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to advance its drug candidate, GNC-077, into clinical trials for the treatment of advanced solid tumors. GNC-077 is a multi-specific antibody developed on…
-
SciClone Pharmaceuticals Gets NMPA Approval for Phase III Study of First-in-Class SERD Orserdu
•
SciClone Pharmaceuticals Inc. (HKG: 6600), a Chinese pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III bridging study for its drug Orserdu (elacestrant), the world’s first selective estrogen receptor degrader (SERD) originally developed by Eisai. The Phase III study, which is randomized,…
-
ApolloBio’s HPV Therapeutic Vaccine VGX-3100 Gets NMPA Green Light for Clinical Trial
•
ApolloBio Corp., a joint stock company of China’s leading cephalosporin manufacturer Jincheng Pharmaceutical Group Co., Ltd. (SHE: 300233), has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for VGX-3100. This drug, hailed as the world’s first therapeutic vaccine for human papillomavirus (HPV), is…
-
Jacobio Pharma’s Pan-KRAS Inhibitor JAB-23E73 Clears FDA Hurdle for Clinical Trials
•
Jacobio Pharma (HKG: 1167), a biopharmaceutical company based in China, has received the green light from the U.S. Food and Drug Administration (FDA) to commence a Phase I/IIa clinical study for its investigational new drug, JAB-23E73. This in-house developed pan-KRAS inhibitor has shown promise in simultaneously inhibiting both active and…
-
Yantai Dongcheng Pharmaceutical’s 18F-LNC1007 Receives Clinical Clearance for Solid Tumor Diagnostics
•
Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a Chinese pharmaceutical company, has received clinical trial approval from the National Medical Products Administration (NMPA) for its 18F-LNC1007 injection, a novel radioactive diagnostic drug. This drug is designed to target fibroblast activating protein (FAP) and integrin alpha-v beta-3, which are biomarkers…
-
Fosun Pharmaceutical’s PD-1 Inhibitor HanSiZhuang Recommended for Approval by EMA’s CHMP
•
Shanghai Fosun Pharmaceutical Group Co., Ltd (SHA: 600196; HKG: 2196), a leading pharmaceutical company in China, has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending the approval of its anti-programmed death-1 (PD-1) inhibitor, HanSiZhuang, in combination with carboplatin and…
