Clinical & Regulatory
Gracell Biotechnologies Initiates Investigational Study Evaluating GC012F for Treatment of Refractory Systemic Lupus Erythematosus (SLE)
SAN DIEGO, Calif., SUZHOU and SHANGHAI, China, May 15, 2023 /PRNewswire/ -- Gracell Biotechnologies Inc. ("Gracell" or the "Company", NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer and autoimmune diseases, today announced the initiation of an investigator-initiated trial (IIT) in China of GC012F, the Company's autologous FasTCAR therapeutic candidate dual-targeting B cell maturation antigen (BCMA) and CD19, for the treatment of refractory SLE.
CARsgen Initiates Phase 2 Clinical Trial for CLDN18.2 CAR T-cell Product CT041 in the U.S.
SHANGHAI, May 18, 2023 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announced that CARsgen has initiated patient enrollment for Phase 2 of the clinical trial for CT041 in the U.S., for the treatment of CLDN18.2 positive advanced gastric cancer/gastroesophageal junction cancer (GC/GEJ) in patients who have failed at least 2 prior lines of systemic therapies.
Everest Medicines Announces Completion of Patient Enrollment in Phase 3 Clinical Trial of Etrasimod in Asia
SHANGHAI, May 16, 2023 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, announced today the completion of patient enrollment in a multi-center Phase 3 clinical trial of etrasimod in Asia for the treatment of moderate-severe active ulcerative colitis (UC).
Transcenta Announces Encouraging Phase I Clinical Data of TST002 (Blosozumab) in Chinese Patients with Reduced Bone Mineral Density
SUZHOU, China, May 16, 2023 /PRNewswire/ -- Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces encouraging phase I clinical data of TST002 (Blosozumab) in Chinese patients with reduced bone mineral density (BMD). TST002 (Blosozumab) was well tolerated and significantly increased BMD at day 85 following single intravenous injection at various doses.
LYNK’s LNK01001 Achieved Exciting Phase II Results in Rheumatoid Arthritis
HANGZHOU, China, May 16, 2023 /PRNewswire/ -- Lynk Pharmaceuticals Co., Ltd. (hereinafter referred to as 'Lynk Pharmaceuticals'), an innovative clinical stage company, announced that the Phase II clinical trial of LNK01001 in the treatment of rheumatoid arthritis (RA) showed statistically significant differences in efficacy compared with placebo in both primary and key secondary efficacy endpoints, and demonstrated good safety and tolerability.
Innovent Receives NMPA Breakthrough Designation for IBI351 (KRASG12C Inhibitor) as Monotherapy for Previously Treated Advanced Colorectal Carcinoma
ROCKVILLE, Md. and SUZHOU, China, May 14, 2023 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI351 (GFH925) for the treatment of previously treated advanced colorectal carcinoma (CRC) patients with KRASG12C mutation.
Nefecon Included in the Reimbursement Drug List of “Beijing Puhui Health Insurance Program” as a First-in-Disease Therapy for IgA Nephropathy
SHANGHAI, May 11, 2023 /PRNewswire/ -- An imported version of Nefecon (budesonide) delayed release capsule has been added to the 2023 New Reimbursement Drug List of Specialized Medicines of the "Beijing Puhui Health Insurance Program." Nefecon is a first-in-disease treatment for adults with primary immunoglobulin A nephropathy (IgAN).
LianBio Announces Marketing Approval of CAMZYOS® (mavacamten) in the Macau Special Administrative Region (SAR) of China
SHANGHAI, China and PRINCETON, N.J., May 11, 2023 (GLOBE NEWSWIRE) -- LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, today announced that CAMZYOS® (mavacamten) has received marketing approval for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) from the Pharmaceutical Administration Bureau of the Macau SAR.
Kintor Pharma Announces Successful Completion of Phase II Clinical Trial of KX-826 for Treatment of Androgenetic Alopecia in the US
SUZHOU, China, May 11, 2023 /PRNewswire/ -- Kintor Pharmaceutical Limited ("Kintor Pharma", HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecules and biological therapeutics, announced that the Phase II clinical trial of in-house developed KX-826 for the treatment of male androgenetic alopecia ("AGA") in the US has been completed successfully.
Innovent Announces Phase 2 Clinical Study of Higher dose 9 mg Mazdutide (IBI362) in Chinese Adults with Obesity Achieved the 24-Week Primary Endpoint
ROCKVILLIE, Md. and SUZHOU, China, May 10, 2023 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, today announced that the phase 2 clinical study of higher dose (9 mg) mazdutide (Innovent R&D Code: IBI362) in Chinese adults with obesity achieved the 24-week primary endpoint.
