Clinical & Regulatory
LianBio Completes Enrollment in Pivotal Phase 3 LIBRA Trial of TP-03 in Chinese Patients with Demodex Blepharitis
LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, today announced the completion of enrollment in the Phase 3 LIBRA clinical trial of TP-03 in Chinese patients with Demodex blepharitis.
China Approves the World’s First Vaccine against XBB Descendent Lineages of SARS-CoV-2 for Emergency Use
On June 8th, 2023, Coviccine® Trivalent XBB.1.5-Recombinant COVID-19 Trivalent (XBB.1.5+BA.5+Delta) Protein Vaccine (Sf9 cell) developed by WestVac Biopharma/ West China Medical Center, Sichuan University was approved for EUA by relevant authorities in China.
LianBio Announces Topline Results from Phase 2a Proof of Concept Trial Evaluating Infigratinib in Patients with Gastric Cancer & Receipt of Breakthrough Therapy Designation in China
LianBio announced positive topline results from a Phase 2a proof of concept trial evaluating infigratinib in Chinese patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with fibroblast growth factor receptor-2 (FGFR2) gene amplification.
Innovent Announces the Second Breakthrough Therapy Designation by NMPA for Olverembatinib for the Treatment of Patients with SDH-Deficient GIST
Innovent Biologics, Inc. announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for olverembatinib for the treatment of patients with succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) who had received first-line treatment.
NMPA accepted Akeso’s ebronucimab (PCSK9) marketing application in two cardiovascular indications
Akeso Inc. (9926. HK, "Akeso") announced today that China's National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for its fully human anti-PCSK9 monoclonal antibody ebronucimab (AK102) for 2 indications 1) primary hypercholesterolemia and mixed hyperlipidemia, and 2) heterozygous familial hypercholesterolemia (HeFH).
Brii Biosciences Announces First Subject Dosed in Phase 1 Clinical Trial of BRII-297, Long-Acting Injectable for the Treatment of Anxiety and Depressive Disorders
Brii Biosciences Limited ("Brii Bio" or the "Company", stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet need, today announced the first subject has been dosed in a Phase 1 clinical trial evaluating BRII-297, a first-of-its-kind long-acting injectable (LAI), in development for the treatment of various anxiety and depressive disorders.
Sirnaomics Dosed the First Patient in Phase I Clinical Study of GalNAc-Based RNAi Therapeutic STP122G for Anticoagulant Treatment
Sirnaomics Ltd. (the "Company"; together with its subsidiaries, the "Group" or "Sirnaomics"; stock code: 2257), a leading biopharmaceutical company engaging in discovery and development of advanced RNAi therapeutics, today announced it has dosed the first participant in a Phase I clinical trial of STP122G for anticoagulation treatment.
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).
