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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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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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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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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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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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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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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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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 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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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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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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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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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…
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The Center for Drug Evaluation (CDE) has granted prioritized review status to InnoCare Pharma’s (HKG: 9969) orelabrutinib (a Bruton’s tyrosine kinase, BTK inhibitor) and CStone Pharmaceuticals’ (HKG: 2616) sugemalimab (a PD-L1 inhibitor, Cejemly). Orelabrutinib is filed for marginal zone lymphoma (MZL), while sugemalimab seeks approval for relapsed/refractory extranodal NK/T-cell lymphoma…
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China-based Biocytogen (Beijing) Co., Ltd and US-based Tracon Pharmaceuticals Inc. (Nasdaq: TCON) announced that the US FDA has approved an IND application to conduct a clinical trial of YH001 in combination with envafolimab or doxorubicin for sarcoma patients, including those who have not been previously treated. Trial DesignThe Phase I/II…
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that its Phase III SHR6390-III-302 study for dalpiciclib, a cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitor, has met pre-set superiority criteria. The drug, combined with letrozole or anastrozole, significantly prolonged progression-free survival (PFS) in patients with HR-positive, HER2-negative advanced breast…
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its anti-CD70 antibody IMM40H, following a previous US clinical nod. The drug is designed to target CD70, a protein found in highly activated lymphocytes and a viable target for…
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Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) announced positive results from a Phase II study of STP705 for basal cell carcinoma (BCC). The open-label, dosage escalation trial showed 100% complete remission (CR) in the 180 μg dose cohort, with stable or improved cosmetic outcomes in all subjects. The treatment…
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Shanghai Henlius Biotech Inc. (HKG: 2696) announced that the National Medical Products Administration (NMPA) has accepted a supplementary Biologic License Application (BLA) for its PD-1 inhibitor Serplulimab (HaiSiZhuang) in combination with cisplatin and fluorouracil (5-FU) for first-line treatment of locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). Additionally,…
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Junshi Biosciences (HKG: 1877, SHA: 688180) has received approval from the National Medical Products Administration (NMPA) to conduct a clinical trial for its injectable monoclonal antibody TAB009/JS009, targeting CD112R, as a monotherapy for advanced solid tumors. The company also plans to initiate a US trial for its XPO1 inhibitor JS110…