J&J’s Darzalex SC Becomes First Oncology Injectable in Europe Approved for Patient Self-Administration
Johnson & Johnson (J&J, NYSE: JNJ) announced that the Committee for Medicinal Products for Human...
Cancer
Enhertu Wins China Approval for HER2+ Early Breast Cancer – ADC Sequential Therapy Shows 67% pCR Rate in Phase III DESTINY-Breast11
Enhertu (trastuzumab deruxtecan), the HER2-targeted antibody-drug conjugate (ADC) co-developed by AstraZeneca (NYSE: AZN) and Daiichi...
Chengdu Kanghong’s KHN922 Wins NMPA Approval – Dual-Payload HER3 ADC Targets Advanced Solid Tumors with Anti-Resistance Mechanism
Chengdu Kanghong Pharmaceutical Group Co., Ltd. (SHE: 002773) announced clinical trial approval from China’s National...
Huadong Medicine’s HDM2024 Wins NMPA Approval – EGFR/HER3 Bispecific ADC Targets Advanced Solid Tumors
Huadong Medicine Co., Ltd. (SHE: 000963) announced clinical trial approval from China’s National Medical Products...
CStone’s Sugemalimab Wins ESMO [I, A] Recommendation – PD-L1 Inhibitor Targets Stage III NSCLC Consolidation Therapy in Europe
CStone Pharmaceuticals (HKG: 2616) announced that sugemalimab received a class recommendation in the...
MSD Reportedly Eyes $6 Billion Terns Pharma Acquisition – BCR-ABL Inhibitor TERN-701 Targets Post-Keytruda Oncology Pipelinew333333
Merck, Sharp & Dohme (MSD; NYSE: MRK) is reportedly preparing to acquire Terns Pharmaceuticals (NASDAQ:...
Changchun High-Tech Wins FDA Orphan Drug Designation for GenSci128 – TP53 Y220C Reactivator Targets Gastric Cancer
Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced that GenSci128 received Orphan...
Asieris Pharma Partners with SPH Keyuan to Commercialize Cevira – World’s First Non‑Surgical Cervical Precancer Treatment Launches in China
Jiangsu Asieris Pharmaceuticals Co., Ltd. (SHA: 688176), a urogenital cancer specialist, has entered into a...
Qilu Pharma’s QLS31905 Wins FDA Orphan Drug Designation – First‑in‑Class Claudin18.2/CD3 Bispecific Enters Phase III for Pancreatic Cancer
Qilu Pharmaceutical Co., Ltd. announced that QLS31905, its Claudin18.2/CD3 bispecific T‑cell engager (BsAb), has received...
IASO Bio Wins Japan PMDA Approval for Fucaso CAR‑T – BCMA Therapy Enters Phase III in Relapsed/Refractory Multiple Myeloma
IASO Biotherapeutics announced receiving tacit clinical approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA)...
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...
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...