Greater China News
AffaMed Therapeutics Announces Completion of Patient Enrollment in the Real-World Study in China Evaluating the Safety and Efficacy of DEXTENZA® in Cataract Surgery Patients
AffaMed Therapeutics ("AffaMed"), a global biotechnology company dedicated to developing and commercializing transformative pharmaceutical, digital and surgical products that address critical unmet medical needs in ophthalmological, neurological and psychiatric disorders, today announced the completion of patient enrollment in the Real-World Study ("RWS") conducted in the Boao Lecheng Pilot Zone in Hainan, China, to evaluate the safety and efficacy of DEXTENZA® (0.4 mg dexamethasone ophthalmic insert) for the treatment of ocular inflammation and pain following cataract surgery.
CANbridge Announces Full Enrollment Reached in China Region of the Global LIVMARLI® (CAN108) EMBARK Phase 2 Study in Biliary Atresia
CANbridge Pharmaceuticals Inc. (HKEX:1228), a leading China-based global biopharmaceutical company committed to the research, development and commercialization of transformative rare disease and rare oncology therapies, announced that the China region of the global Phase 2EMBARK study of LIVMARLI® (maralixibat) oral solution (CAN108) in biliary atresia (BA) is fully enrolled, with nearly twice the expected number of patients.
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).
PharmaEssentia Selects Pint-Pharma as Commercial Partner for BESREMi® (ropeginterferon alfa-2b-njft) in Latin America
PharmaEssentia Corporation (TPEx:6446), a leading fully integrated biopharmaceutical company in Taiwan, today announced that it has entered into an exclusive license agreement with Pint-Pharma GmbH for the registration and promotion of BESREMi® (ropeginterferon alfa-2b-njft) for the treatment of polycythemia vera (PV), a rare blood cancer, in Brazil, Argentina, Colombia, Chile, Peru, Ecuador, and Mexico.
Impact Therapeutics Entered into Global Partnership with Eikon Therapeutics to Develop and Commercialize PARP1 Selective Inhibitors
IMPACT Therapeutics ("Impact"), a biopharmaceutical company focusing on the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality, and Eikon Therapeutics ("Eikon"), a biotechnology company that is advancing breakthrough therapeutics through the purposeful integration of engineering and science today announced that the companies have entered into a global license and collaboration agreement for PARP1 selective inhibitors including IMP1734, which is anticipated to enter into Phase I clinical study in 2023.
