Clinical & Regulatory
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.
Formosa Pharmaceuticals and AimMax Therapeutics Announce the NDA Submission to the US FDA for APP13007 for the Treatment of Post-Operative Inflammation and Pain following Ocular Surgery
Formosa Pharmaceuticals, Inc. (6838.TWO) and AimMax Therapeutics, Inc. (United States) announce the submission of a New Drug Application to the United States Food & Drug Administration (US FDA) for APP13007, a novel aqueous nanosuspension formulation of the potent corticosteroid, clobetasol propionate (0.05%), for the treatment of inflammation and pain following ocular surgery.
ABM Announces First Patient Dosed in Phase I Clinical Trial of MEK Inhibitor for Solid Tumor
ABM Therapeutics, an innovative clinical-stage biopharmaceutical company, with an emphasis on developing drugs with high blood–brain barrier (BBB) penetration for CNS diseases including brain metastases, today announced that the first patient was successfully dosed with ABM-168 in the United States.
Ascletis Announces ASC40, a First-in-Class, Once-Daily Oral FASN Inhibitor, Achieved Endpoints in Phase II Clinical Trial for Acne
Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that ASC40 (Denifanstat), a first-in-class, once-daily oral fatty acid synthase (FASN) inhibitor, achieved primary and key secondary endpoints in Phase II clinical trial for acne vulgaris.
EirGenix’s Second Breast Cancer Biosimilar EG1206A Successfully Reaches Phase 1 Clinical Trial Objectives
EirGenix, Inc. (6589.TT) announced on 28th of April that it has completed the phase 1 clinical trial (EGC101) of its second breast cancer biosimilar EG1206A in Europe.
