Clinical & Regulatory
Connect Biopharma Announces Positive Long-Term Data from the Maintenance Period Through Week 48 of CN002 Phase 2 Icanbelimod Trial in Patients with Moderate-to-Severe Ulcerative Colitis
Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect Biopharma” or the “Company”), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, today announced positive data at Week 48 from Phase 2 trial (CN002) for icanbelimod (formerly known as CBP-307), a once-daily, orally administered, selective sphingosine 1-phosphate receptor 1 (S1P1) modulator in development for the treatment of ulcerative colitis (UC).
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).
BRUKINSA® Approved in Canada for the Treatment of Chronic Lymphocytic Leukemia
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, announced today that BRUKINSA (zanubrutinib), a Bruton's tyrosine kinase inhibitor (BTKi),has been approved by Health Canada for the treatment of adult patients with chronic lymphocytic leukemia (CLL).
Lynk Pharmaceuticals Completes 200 Million RMB Series C1 Financing to Accelerate Clinical Development of Core Products
Lynk Pharmaceuticals Co., Ltd. (hereinafter referred to as 'Lynk Pharmaceuticals'), an innovative clinical stage company, today announced the successful completion of a RMB 200 million Series C1 financing round.
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.
