Clinical & Regulatory
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.
SINOVAC’s CoronaVac® Answers Hong Kong’s Need for Self-Pay COVID-19 Vaccines
HONG KONG--(BUSINESS WIRE)-- Sinovac Biotech Ltd. ("SINOVAC" or the "Company") (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, today announced it will provide its inactivated COVID-19 vaccine, CoronaVac® (original strains), to self-paying groups in Hong Kong.
Innovent Announces First Participant Dosed in Phase 3 Study (RESTORE) of IBI311 (Anti-IGF-1R Monoclonal Antibody) in Patients with Thyroid Eye Disease
ROCKVILLE, MD. and SUZHOU, China, May 7, 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, announces that the first patient with Thyroid Eye Disease (TED) has been successfully dosed in the Phase 3 study (RESTORE) of IBI311, a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody.
Ascletis Announces China NMPA Approval of Conducting a Phase IIa Clinical Trial for ASC10 to Treat Respiratory Syncytial Virus Infection
HANGZHOU and SHAOXING, China, May 8, 2023 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that the China National Medical Products Administration ("NMPA") has approved to conduct a Phase IIa clinical trial for ASC10 to treat respiratory syncytial virus (RSV) infection.
BeiGene Receives New Approvals for BRUKINSA® (zanubrutinib) in China
BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced the China National Medical Products Administration (NMPA) approved four applications for BRUKINSA (zanubrutinib), the company’s Bruton’s tyrosine kinase inhibitor (BTKi).
Suzhou GenAssist Therapeutic Co.,Ltd recently announced that its first base editing product, GEN6050, has submitted a pre-IND application to the FDA and has been accepted
SUZHOU, China, May 6, 2023 /PRNewswire/ -- Suzhou GenAssist Therapeutic Co.,Ltd recently announced its pre-IND application of their first base editing product, GEN6050 and the acceptance by the FDA.
Targeting RAS: Golden Biotech Announces Positive Results with Longer Survival Compared with Standard Treatments from Interim Analysis of Phase 2 Trial for Antroquinonol as 1st Line Treatment for Stage 4 Metastatic Pancreatic Cancer
Golden Biotechnology Corp. (TPEX 4132) ("GoldenBiotech", GBC), an advanced biopharmaceutical drug development company, announces the release of positive interim results from its Phase II clinical trial of Antroquinonol (HOCENA®) in combination with the standard of care (SOC) nab-paclitaxel + gemcitabine for first-line treatment of metastatic pancreatic cancer.
