Kelun‑Biotech’s SKB103 Wins NMPA Approval – Novel TAA‑PD‑L1 Bispecific ADC Enters Clinical Trials for Advanced Solid Tumors
Sichuan Kelun‑Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced that its SKB103, a novel TAA‑PD‑L1 bispecific...
Cancer
Chipscreen Biosciences Licenses Epidaza to Nizhpharm – $29M Deal Expands HDAC Inhibitor into Central Asia and Eastern Europe
Shenzhen Chipscreen Biosciences Co., Ltd. (SHA: 688321) announced a licensing agreement with Nizhny Novgorod Chemical...
Qilu Pharma’s QLS1317 Wins NMPA Approval – First‑in‑Class MSI‑H Targeted Therapy Enters Solid Tumor Clinical Trials
Qilu Pharmaceutical Co., Ltd. announced that its self‑developed Category 1 innovative drug, QLS1317 tablets, has...
RemeGen Secures Fourth NMPA Approval for Disitamab Vedotin – HER2‑Low Breast Cancer with Liver Metastases Indication Expands ADC Franchise
RemeGen Co., Ltd. (SHA: 688331, HKG: 9995) announced NMPA approval for a new indication of...
Lepu Biopharma Wins NMPA Approval for Perioperative HNSCC Trial – First‑in‑World EGFR ADC + PD‑1 Combination Advances to Clinic
Lepu Biopharma Co., Ltd. (HKG: 2157) announced NMPA IND approval for a groundbreaking Phase II/III...
Hansoh Pharma Wins NMPA Approval for Two Category 1 Drugs – HS‑20152 and HS‑10587 Enter Clinical Trials in Rare Disease and Oncology
Hansoh Pharmaceutical Group Company Limited (HKG: 3692) announced that two Category 1 innovative drugs have...
Hengrui Pharma’s SHR-3836 Wins NMPA Approval for Multiple Myeloma – First-in-Class Anti-Tumor Agent Enters Clinical Development
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that its independently developed drug...
Hengrui Pharma’s HER2 ADC SHR-A1811 Wins NMPA Approval for Breast Cancer – Second Indication Expands Trastuzumab Rezetecan Franchise
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that its self-developed Category 1...
Haihe Biopharma Wins Japan Approval for Risovalisib – First PI3Kα Inhibitor for Ovarian Clear Cell Carcinoma
Haihe Biopharma Co., Ltd. announced that its independently developed selective PI3Kα inhibitor, Risovalisib Mesylate Tablets,...
Huahai Pharmaceutical Initiates Phase III Trial for HB0025 – PD-L1/VEGF Bispecific Targets First-Line Endometrial Cancer
Zhejiang Huahai Pharmaceutical Co., Ltd. (SHA: 600521) announced the initiation of a Phase III clinical...
Konruns Pharma Wins NMPA Phase III Approval for KC1036 – Multi-Target VEGFR2/AXL Inhibitor Targets Thymic Carcinoma
Konruns Pharmaceutical Co., Ltd. (SHA: 603590) received National Medical Products Administration (NMPA) approval to initiate...
Pfizer Reports Positive FOURLIGHT-1 Results for Atirmociclib – CDK4 Inhibitor Shows PFS Benefit in Post-CDK4/6 Breast Cancer
Pfizer Inc. (NYSE: PFE) announced positive topline results from the Phase II FOURLIGHT-1 study, demonstrating...
AstraZeneca Secures EU Approval for Imfinzi in Gastric Cancer – Perioperative Regimen Cuts Death Risk 22% in MATTERHORN Trial
AstraZeneca PLC (NASDAQ: AZN) announced European Union marketing approval for Imfinzi (durvalumab) in combination with...
Henlius Wins NMPA Approval for HLX07 Combination Trial – Anti-EGFR Biologic Plus Serplulimab Targets Squamous NSCLC
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced that subsidiary Shanghai Henlius...
Hengrui’s Irinotecan Liposome (II) Wins NMPA Phase II Approval – Adjuvant Pancreatic Cancer Study vs. Gemcitabine/Capecitabine
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced NMPA clearance to initiate a...
Chipscreen Biosciences’ CS08399 Wins NMPA Approval – PRMT5-MTA Inhibitor Targets MTAP-Deficient Solid Tumors and Lymphomas
Shenzhen Chipscreen Biosciences Co., Ltd. (SHA: 688321) announced NMPA clearance to initiate a clinical study...
J&J’s Erda-iDRS Shows 89% Complete Response in NMIBC – Intravesical Erdafitinib System Advances to Phase II/III
Johnson & Johnson (J&J, NYSE: JNJ) announced positive Phase I results for Erda-iDRS, an investigational...
Sino Biopharm’s TQB3454 Hits Phase III Endpoints in IDH1+ Biliary Tract Cancer – China’s First IDH1 Inhibitor Poised for NDA Filing
Sino Biopharmaceutical (HKG: 1177) announced that TQB3454 Tablets, a Category 1 innovative drug developed by...
Essight Bio’s ES502 Wins FDA Phase I Approval – First TCR×CD3 Bispecific Targeting RAS G12V Mutations Enters Clinic
Shanghai Essight Biotechnology Co., Ltd. announced that ES502 Injection has received FDA approval to proceed...
WuXi Biologics Partners with Earendil Labs – Integrated CDMO Services for Bispecific Antibodies and ADCs Targeting Autoimmune and Oncology Indications
WuXi Biologics (HKG: 2269) announced a strategic cooperation agreement with Earendil Labs, the overseas subsidiary...