Clinical & Regulatory
Antengene Announces XPOVIO® plus Bortezomib and Dexamethasone Included for Reimbursement by the PBS in Australia for the Treatment of Relapsed and/or Refractory Multiple Myeloma
Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, today announced that XPOVIO® (selinexor) in combination with bortezomib and dexamethasone (XVd) is now listed on the PBS for the treatment of adult patients with R/R MM who have received at least one prior therapy.
Ascentage Pharma’s Novel Drug Olverembatinib Recommended for a Breakthrough Therapy Designation in China for the Treatment of SDH-Deficient GIST, the Second BTD for the Drug
Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today that the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has recommended olverembatinib (HQP1351), Ascentage Pharma's lead novel drug candidate, for a Breakthrough Therapy Designation (BTD) for the treatment of patients with succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) who had received first-line treatment.
CANbridge Announces Marketing Approval of CAN108 (迈芮倍®/LIVMARLI®) in China for the Treatment of Cholestatic Pruritus in Patients with Alagille Syndrome
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 that the Chinese National Medical Products Administration (NMPA) has approved CAN108 (Maralixibat Chloride Oral Solution /迈芮倍®/LIVMARLI®) to be marketed for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 1 year of age and older.
China Medical System: An Innovative Drug, ILUMETRI ‘Tildrakizumab Injection’ Approved for Marketing in China
On May 30, China Medical System Holdings Limited ("CMS" or the "Group") announced that on 26 May 2023, the New Drug Application (NDA) of Tildrakizumab Injection under the brand name of ILUMETRI has been approved by the National Medical Products Administration of China (NMPA).
FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults
SILVER SPRING, Md., May 25, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.
HanX Biopharmaceuticals announces HX009 IND approval from FDA
WUHAN, China, May 22, 2023 /PRNewswire/ -- Hanx Biopharmaceuticals, Inc. (HanxBio), announced that the company has received Investigational New Drug (IND) approval to start clinical trial of the potentially first-in-class recombinant anti-CD47/PD-1 bispecific antibody (BsAb), HX009, in Patients with relapsed/refractory Lymphoma.
Lynk Pharmaceuticals Announces First Cohort of Psoriatic Patients Dosed with LNK01004 in Phase Ib Clinical Study
HANGZHOU, China, May 25, 2023 /PRNewswire/ -- Lynk Pharmaceuticals Co., Ltd. (hereinafter referred to as 'Lynk Pharmaceuticals'), an innovative clinical stage company, announced that it has dosed the first cohort of psoriatic patients in a Phase Ib clinical trial of its innovative drug LNK01004.
Structure Therapeutics Initiates Phase 2a Study of Oral GLP-1 agonist GSBR-1290 for the Treatment of Type 2 Diabetes and Obesity
SAN FRANCISCO and SHANGHAI, China, May 25, 2023 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic and pulmonary diseases, today announced that it has dosed the first patient in its Phase 2a study of its highly selective oral GLP-1 agonist GSBR-1290 in adults who are overweight or obese and otherwise healthy, and in adults with type 2 diabetes mellitus (T2DM) who are overweight or obese.
TYK2/JAK1 Inhibitor AC-201 of Accropeutics Bioscience gained Human Research Ethics Committees (HREC) permission for Phase I
SUZHOU, China, May 24, 2023 /PRNewswire/ -- Accropeutics Bioscience announced that its oral small molecule TYK2/JAK1 inhibitor AC-201 has been approved by the Australian Human Research Ethics Committee (HREC) to launch a clinical phase I trial in Australia.
I-Mab Announces Encouraging Phase 1b/2 Study Results of Patients with Advanced NSCLC Receiving Uliledlimab and Toripalimab Combination Therapy at ASCO 2023
GAITHERSBURG, Md. and SHANGHAI, May 25, 2023 /PRNewswire/ -- I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, today announced encouraging results from the Phase 1b/2 study (ClinialTrial.gov Identifier: NCT04322006) evaluating uliledlimab, the Company's proprietary and highly differentiated CD73 antibody, in combination with toripalimab (TUOYI®), a PD-1 antibody, in patients with treatment-naïve advanced non-small cell lung cancer (NSCLC), and exploring the potential value of CD73 expression as a predictive biomarker.
