Greater China News
LianBio Announces Marketing Approval of CAMZYOS® (mavacamten) in Singapore
LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other Asian markets, today announced that CAMZYOS® (mavacamten) has received marketing approval for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) from the Singapore Health Sciences Authority.
Innovent and RemeGen Enter into Clinical Trial Collaboration Investigating Combination Therapy of TYVYT® (sintilimab injection) and Novel ADC Candidates for Advanced Solid Tumors in China
Innovent Biologics (HKEX: 01801) and RemeGen Co. (688331.SH/09995.HK) announced that they entered into a clinical trial collaboration and supply agreement with for the combination therapies of TYVYT® (sintilimab injection) with RC88, a novel mesothelin(MSLN)-targeting antibody-drug conjugate (ADC), or RC108, a novel c-Met-targeting ADC, respectively, as potential treatment options for advanced solid tumors in China.
CANbridge Reports Positive Preliminary Data in the Omoprubart (CAN106) Phase 1b Trial in Paroxysmal Nocturnal Hemoglobinuria (PNH) in China
BEIJING & BURLINGTON, Mass.--(BUSINESS WIRE)--CANbridge Pharmaceuticals, Inc. (1228.HK), a global biopharmaceutical company, with a foundation in China, committed to the research, development and commercialization of transformative therapies to treat rare diseases and oncology, announced positive preliminary results from the ongoing Phase 1b study of omoprubart (CAN106), a novel, long-acting, anti-C5 complement recombinant humanized monoclonal antibody, in paroxysmal nocturnal hemoglobinuria (PNH) in China.
CereVasc & LianMedical Announce Corporate Partnership
CereVasc, Inc., a clinical-stage, medical device company developing novel treatments for neurological diseases, and LianMedical, a medical device company focused on accelerating the introduction of breakthrough medical technologies to markets in Asia, announced today a partnership focused on bringing CereVasc's eShunt® System and related products to patients and providers in China, Hong Kong, Taiwan, and Macaw.
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).
Sanyou Forms Partnership with Hangzhou Zhongmei Huadong Pharmaceutical, Catalyzing Innovative Drug Research and Development
Recently, Sanyou Biopharmaceuticals Co., Ltd. (hereinafter referred to as Sanyou) and Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd, a wholly-owned subsidiary of Huadong Medicine Co., Ltd. (SZ.000963) (hereinafter referred to as Huadong Medicine), signed a license agreement for a collaboratively developed therapeutic biological product.
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.
