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Northeast Pharma Licenses MedAbome’s MAb11-22.1 for ADC and CAR-T Development
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China’s Northeast Pharmaceutical Co., Ltd (SHE: 000597) has signed a licensing agreement with U.S.-based MedAbome to develop the latter’s preclinical monoclonal antibody, MAb11-22.1, for antibody-drug conjugates (ADCs) and chimeric antigen receptor (CAR)-T cell therapies. The deal follows Northeast’s 2017 in-licensing of a Herceptin biosimilar from MedAbome. Collaboration TermsUnder the agreement,…
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Alphamab Oncology Highlights KN046, KN026 Advances at ESMO 2022
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China’s Alphamab Oncology (HKG: 9966) will present updated clinical data for its bispecific antibody candidates KN046 and KN026 at the European Society for Medical Oncology (ESMO) 2022 conference. The programs target multiple cancers, including non-small cell lung cancer (NSCLC) and HER2-positive gastric cancer, with results showing promising efficacy and safety…
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AstraZeneca’s Farxiga Wins China Approval for Chronic Kidney Disease
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UK pharma giant AstraZeneca (AZ, NASDAQ: AZN) announced a new approval for Farxiga (dapagliflozin), its sodium-glucose cotransporter 2 (SGLT2) inhibitor, in China. The drug is now cleared to reduce risks of kidney function decline, end-stage kidney disease, cardiovascular death, and heart failure hospitalization in adults with chronic kidney disease (CKD),…
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Innovent Biologics Doses First Patient in Higher-Dose Mazdutide Obesity Trial
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China’s Innovent Biologics, Inc. (HKG: 1801) announced that the first participant has been dosed in the higher-dose cohort of a Phase II trial for mazdutide (IBI362), a dual agonist targeting glucagon-like peptide 1 receptor (GLP-1R) and glucagon receptor (GCGR), in Chinese adults with obesity. The study follows positive results from…
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Shanghai Pharma’s CD20 Antibody Advances to Primary Nephropathy Trial After NMPA Approval
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China’s Shanghai Pharmaceuticals (HKG: 2607, SHA: 601607) has received approval from the National Medical Products Administration (NMPA) to launch a clinical trial for its CD20 monoclonal antibody (mAb) in primary membranous nephropathy, a chronic kidney disorder with limited treatment options. Study DetailsThe drug, developed by Shanghai Jiaolian Drug R&D Co.,…
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Walvax Biotech Wins NMPA Approval for mRNA and Recombinant COVID-19 Vaccines
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China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has received clinical trial approvals from the National Medical Products Administration (NMPA) for two novel coronavirus vaccines: an mRNA vaccine co-developed with Fudan University and Shanghai RNACure Biopharma, and a recombinant vaccine developed in-house by its subsidiary Shanghai Zerun Biotech. Vaccine Details Strategic…
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China’s Pharmaceutical Industry Sees Revenue Decline Amid Export Shifts
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China’s pharmaceutical manufacturing sector reported a 1.8% year-on-year (YOY) revenue decline to RMB 1.6 trillion (USD 231 billion) in the latest National Bureau of Statistics (NBS) data, alongside a 30.7% plunge in profits to RMB 247.36 billion (USD 35.8 billion). Meanwhile, the China Chamber of Commerce for Import and Export…
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CARsgen Therapeutics Launches GMP Manufacturing for CAR-T Cell Therapies in North Carolina
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China’s CARsgen Therapeutics Holdings Ltd (HKG: 2171), a chimeric antigen receptor (CAR)-T cell specialist, has initiated Good Manufacturing Practice (GMP)-compliant production at its new autologous CAR-T cell therapy plant in North Carolina’s Research Triangle Park (RTP). The facility marks the company’s first manufacturing site outside China and will supply clinical…
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Hengrui Medicine’s HRG2101 Inhaler Wins NMPA Approval for IPF Clinical Trial
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China’s Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to conduct a clinical trial of its HRG2101 inhaler for idiopathic pulmonary fibrosis (IPF). The drug, with no similar marketed products in China, targets fibroblast activity and inflammatory pathways to address the…
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RedCloud Bio Doses First Patient in H002 EGFR TKI Phase I/IIa Trial for NSCLC
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Shanghai-based RedCloud Bio announced that the first patient has been dosed in a Phase I/IIa multi-center trial of H002, its fourth-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), for non-small cell lung cancer (NSCLC) patients with resistance to prior TKIs, including C797S mutations. Drug ProfileH002, discovered in-house by…
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Lepu Biopharma’s MRG002 Earns FDA Orphan Drug Status for Gastric Cancer
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China’s Lepu Biopharma Co., Ltd (HKG: 2157) announced that the U.S. FDA has granted orphan drug designation (ODD) to its antibody-drug conjugate (ADC) MRG002 for gastric cancer and gastroesophageal junction adenocarcinoma (GC/GEJ). The drug is in a Phase I/II trial in the U.S. targeting HER2-positive, advanced or metastatic GC/GEJ. Drug…
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CDE Releases 62nd Batch of Chemical Generic References, Updates 39 Specifications
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The Center for Drug Evaluation (CDE) has released the 62nd batch of chemical generic reference preparations, marking a significant update to its regulatory framework. This latest batch includes 27 new specifications and updates information on 39 previously published specifications, reflecting ongoing efforts to enhance the transparency and efficiency of China’s…
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Jacobio Pharmaceuticals Doses First Patient in JAB-21822 Phase IIa Trial for KRAS G12C NSCLC
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China’s Jacobio Pharmaceuticals Group Co., Ltd (HKG: 1167) announced the first patient dosed in a Phase IIa trial of its KRAS G12C inhibitor, JAB-21822, for first-line non-small cell lung cancer (NSCLC) with KRAS G12C and STK11 co-mutations. The study follows a Phase I trial that showed a 56.3% objective response…
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Akeso Bio’s AK112 Wins Breakthrough Designation for First-Line NSCLC
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China’s Akeso Bio has secured a breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) for its bispecific antibody (BsAb) AK112, targeting programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF), in first-line, locally advanced, or metastatic non-small cell lung cancer (NSCLC) with PD-L1 expression (TPS≥1%). The drug…
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Connect Biopharma Completes Phase I Trial of CBP-174 for Itch in Skin Diseases
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Sino-US biotech Connect Biopharma Holdings Ltd (NASDAQ: CNTB), headquartered in San Diego, California, and Taicang, Suzhou, China, announced the completion of a Phase I study for CBP-174, its small-molecule H3 receptor antagonist. The drug is being developed to treat pruritus (itch) associated with allergic and inflammatory skin diseases, including atopic…
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Boehringer, Eli Lilly’s Jardiance Wins NMPA Approval for Heart Failure with Preserved Ejection Fraction
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Boehringer Ingelheim and Eli Lilly (NYSE: LLY) announced that China’s National Medical Products Administration (NMPA) has approved a new indication for Jardiance (empagliflozin), an SGLT2 inhibitor, to treat heart failure in adult patients with preserved ejection fraction (HFpEF). Previously approved in China for type 2 diabetes and heart failure with…
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Merck’s Gardasil 9-Valent HPV Vaccine Approved for Expanded Age Range in China
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US-based Merck Sharp & Dohme (MSD; NYSE: MRK) announced that China’s National Medical Products Administration (NMPA) has approved an expanded indication for its Gardasil 9-valent human papillomavirus (HPV) vaccine. The vaccine, initially approved for females aged 16–26, can now be administered to females aged 9–45. Vaccine Details Epidemiological Context Vaccination…
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Sinocelltech’s Ripertamab Wins NMPA Approval for DLBCL Treatment
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China-based Sinocelltech Group Ltd (SHA: 688520) has received New Drug Application (NDA) approval from the National Medical Products Administration (NMPA) for its biosimilar ripertamab (SCT400), a CD20 monoclonal antibody (mAb) targeting newly diagnosed CD20-positive diffuse large B-cell non-Hodgkin lymphoma (DLBCL). Drug ProfileRipertamab is a biosimilar of Roche’s Mabthera (rituximab) and…
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Clover Biopharma’s SCB-2019 Vaccine Shows Strong Immune Response to Omicron BA.5
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China-based Clover Biopharmaceuticals, Ltd (HKG: 2197) announced positive Phase II/III trial results for its COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum), demonstrating a robust immune response against the Omicron BA.5 subvariant, the dominant strain globally. Trial DesignThe global, double-blind, randomized, controlled SPECTRA trial included two cohorts: Immune Response
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Staidson and J&J’s Teclistamab Gain Breakthrough Designation for Hemophilia and Myeloma
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The Center for Drug Evaluation (CDE) has indicated that Staidson (Beijing) Pharmaceutical Co., Ltd’s (SHE: 300204) STSP-0601 and Johnson & Johnson’s teclistamab are set to receive breakthrough therapy designations (BTDs). STSP-0601 is indicated for on-demand treatment of bleeding in hemophilia A or B patients with inhibitors, while teclistamab targets relapsed…
