Clinical & Regulatory
Junshi Biosciences Announces Initiation of Phase 3 Study of Tifcemalimab plus Toripalimab for Treatment of Limited-stage Small Cell Lung Cancer
Shanghai Junshi Biosciences Co., Ltd (HKEX: 1877; SSE: 688180) announced that the U.S. Food and Drug Administration (“FDA”) has recently agreed a randomized, double-blind, placebo-controlled, multi-regional phase 3 clinical study of tifcemalimab (product code: TAB004/JS004), an anti-BTLA monoclonal antibody used in combination with toripalimab, an anti-PD-1 monoclonal antibody, as consolidation therapy for patients with limited-stage small cell lung cancer without disease progression following chemoradiotherapy may proceed.
Jacobio Pharma Presents Clinical Results of Glecirasib in Colorectal Cancer
Jacobio Pharma (1167.HK) announced clinical results of its novel KRAS G12C inhibitor glecirasib monotherapy and in combination therapy with cetuximab to treat KRAS G12C mutant advanced CRC (colorectal cancer) in Second JCA- AACR Precision Medicine International Conference.
Drug Farm Announces IND Clearance by U.S. FDA Enabling Phase 1 Initiation for First-in-Class Oral ALPK1 Selective Kinase Inhibitor, DF-003
Drug Farm announced today the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application of DF-003, a first-in-class, oral, potent, highly selective ALPK1 inhibitor for clinical evaluation.
Harbour BioMed Announces Biologics License Application Acceptance of Batoclimab for Treatment of Generalized Myasthenia Gravis by NMPA
Harbour BioMed (HKEX: 02142) announced that the National Medical Products Administration (NMPA) of China has accepted the Biologics License Application (BLA) of batoclimab (HBM9161) for the treatment of generalized myasthenia gravis (gMG).
Caliway Announces Positive Data from CBL-0201EFP Phase 2-Stage 1 Study of CBL-514 in Treating Moderate to Severe Cellulite
Caliway Biopharmaceuticals (Caliway), a Taiwan-based biopharmaceutical company focusing on breakthrough medical aesthetics and inflammatory medicine discovery of small-molecule therapeutics, today announced that the CBL-0201EFP Phase 2-Stage 1 results demonstrated the significant cellulite severity improvement with a single CBL-514 treatment.
Aurisco gets Auxiton® (Dydrogesterone) as first generic approval in China
Aurisco Pharmaceutical received its first Marketing Authorization Approval in China for AUXITON®, the oral finished dosage form of Dydrogesterone, from China's Health Authority, the NMPA.
Xuanzhu Biopharm, a subsidiary of Sihuan Pharmaceutical, Its Innovative Drug Anaprozole Sodium Enteric-coated Tablets Obtains Drug Registration Approval From NMPA
Sihuan Pharmaceutical Holdings Group Ltd together with its subsidiaries, announced that Xuanzhu Biopharmaceutical Co. received a drug registration approval from China's NMPA of Anaprozole Sodium Enteric-coated Tablet for the treatment of duodenal ulcer.
To ease cancer drug shortage, FDA will allow imports from China
The Food and Drug Administration is working with a Chinese drugmaker to import the chemotherapy drug cisplatin, a strategy aimed at ramping up supply amid an ongoing shortage of the drug in the United States.
Minghui Pharmaceutical Inc. Announces First Patient Dosing in Phase 1 Clinical Studies of Both the Antibody-Drug Conjugate Programs Targeting TROP-2 or B7-H3 Respectively, for Treatment of Advanced or Metastatic Solid Tumors
SHANGHAI and HANGZHOU, China and WILMINGTON, Del., June 20, 2023 /PRNewswire/ -- Minghui Pharmaceutical, Inc., a leading clinical-stage biopharmaceutical company, announced today that the first dosing has been completed in two phase 1 clinical studies evaluating MHB036C and MHB088C.
BioCity Announces Initiation of a Phase 2 Trial for SC0062, a Promising ETA Receptor Antagonist for Chronic Kidney Disease
WUXI, China, June 21, 2023 /PRNewswire/ -- BioCity Biopharma, a clinical-stage biopharmaceutical company committed to developing novel and highly differentiated, modality-independent therapeutics for cancer and autoimmune disorders, today announced the initiation of a randomized, placebo-controlled Phase 2 clinical trial of its novel, oral endothelin A (ETA)-receptor selective antagonist, SC0062, with the enrollment of two patients with IgA nephropathy（IgAN）in China（NCT05687890）.
