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Neukio Biotherapeutics Completes USD 50M Series A-1 Financing for iPSC-CAR-NK Therapy
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Shanghai-based Neukio Biotherapeutics, a developer of iPSC-derived chimeric antigen receptor natural killer (CAR-NK) cell therapies, announced the completion of a USD 50 million Series A-1 financing round. The funding, led by CD Capital, will support pre-clinical validation, clinical trials, and talent recruitment for its universal off-the-shelf CAR-NK pipeline. Financing DetailsThe…
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Acorda Therapeutics Licenses Preclinical Drug Nepicastat to China’s Asieris
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US-based Acorda Therapeutics Inc. (Nasdaq: ACOR) announced a licensing agreement with China’s Asieris Pharmaceuticals for its preclinical drug candidate nepicastat, a small-molecule inhibitor of dopamine beta-hydroxylase (DBH). Asieris will develop the drug for non-psychiatric indications, with a focus on cardiovascular diseases linked to sympathetic nervous system overactivation. Deal TermsUnder the…
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SAMR Issues New Rules for Online Drug Sales in China
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China’s State Administration for Market Regulation (SAMR) has released the “Measures for the Supervision and Administration of Online Drug Sales,” effective December 1, 2022. The 42-article regulation aims to ensure drug quality, safety, and accessibility, targeting online retailers, platforms, and prescription drug sales. Drug Operator ResponsibilitiesThe rules clarify qualifications for…
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NMPA Designates Shijiazhuang Airport as Drug Import Port for Narcotics, Psychotropics
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China’s National Medical Products Administration (NMPA) has designated Shijiazhuang Airport in Hebei Province as an official drug import port, following approval from the State Council. The move allows the import of select Chinese medicines, chemicals, narcotics, and psychotropic drugs through the airport. Port ResponsibilitiesThe Shijiazhuang market administration bureau has been…
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Henlius Biotech Plans US Bridging Study for Serplulimab in ES-SCLC
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Shanghai Henlius Biotech (HKG: 2696) is advancing its checkpoint inhibitor serplulimab toward the U.S. market, with plans to launch a bridging study in H2 2022 for extensive-stage small-cell lung cancer (ES-SCLC). The decision follows a meeting with the U.S. FDA, as the firm seeks to replicate its Phase III success…
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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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Novartis Partners with Beijing’s Changping District to Expand Drug Development
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Swiss pharma giant Novartis (NYSE: NVS) has partnered with Beijing’s Changping district government to expand its business footprint in the region, focusing on novel drug development and digital health collaborations. The alliance will drive pilot projects and support local innovation in treatment technologies. Partnership DetailsAnnounced in an online meeting between…
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GenScript Biotech’s H1 2022 Revenue Rises 32.7% on Carvykti CAR-T Sales
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Nanjing-based GenScript Biotech, a biopharma and contract research firm, reported a 32.7% year-on-year (YOY) revenue increase to USD 304.7 million for H1 2022. The growth was driven by sales from its CAR-T cell therapy partnership with Johnson & Johnson’s Janssen, offsetting rising group losses. Revenue Breakdown Carvykti MilestonesCarvykti received U.S.…
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Mayo Clinic Launches Mayflower BioVentures to Accelerate Cell and Gene Therapies
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The Mayo Clinic, a leading US hospital group, has launched Mayflower BioVentures, a cell and gene therapy accelerator, in partnership with Hibiscus BioVentures and Innoforce Pharmaceuticals. The venture aims to translate lab technologies into viable therapies for unmet patient needs, with leadership from Mayo Clinic clinicians and Hibiscus executives. Collaboration…
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Biointron Raises USD 72M in Series B to Expand CRO Services and Antibody Platform
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Shanghai-based Biointron, a recombinant protein/antibody reagent contract research organization (CRO), has raised nearly RMB 500 million (USD 72.4 million) in a Series B round led by Cornerstone Capital, LYFE Capital, and Sky World Capital. The funding will enhance its CRO service capacity, smart manufacturing, R&D, and global expansion. Funding DetailsThe…
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Simcere Pharma’s H1 2022 Revenue Rises 27% on New Drug Sales, R&D Push
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Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) reported RMB 2.7 billion (USD 391 million) in H1 2022 revenue, up 27.3% year-on-year (YOY), driven by commercialization of six novel drugs. R&D spending hit RMB 652 million (USD 94.4 million), while net profits fell 88.8% YOY to RMB 62 million (USD 8.9…
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Alphamab Oncology Reports H1 2022 Revenue Growth Driven by Envafolimab Commercialization
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China-based Alphamab Oncology (HKG: 9966) reported RMB 53.57 million (USD 7.7 million) in H1 2022 revenue, primarily from commercialization and licensing of envafolimab, its PD-L1 inhibitor co-developed with Simcere Pharma and 3D Medicines. The firm also posted RMB 38.75 million (USD 5.6 million) in gross profits. Envafolimab CommercializationEnvafolimab, China’s first…
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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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RemeGen’s H1 2022 Revenue Soars 1,094% on Aidixi, Taiai Sales
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China-based biotech RemeGen (HKG: 9995) reported RMB 349 million (USD 50.5 million) in revenue for H1 2022, a 1,094.8% year-on-year surge, driven by sales of its two marketed products: Aidixi (disitamab vedotin), a HER2-targeted ADC for cancer, and Taiai (telitacicept), a fusion protein for autoimmune diseases. Product Approvals and Trials…
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Beijing Adjusts UEBMI Account Management, Boosting Outpatient Coverage
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The Beijing Municipal Medical Insurance Bureau has adjusted the management of Urban Employee Basic Medical Insurance (UEBMI) accounts, effective September 1. Employee contributions to Basic Medical Insurance (BMI) will now be fully allocated to personal accounts, while employer contributions will go to unified accounts. Retirees will receive a fixed allocation…
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Junshi Biosciences’ H1 2022 Financials Show Tuoyi Sales Growth Despite Revenue Drop
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Shanghai-based Junshi Biosciences (HKG: 1877) reported a 55.26% year-on-year (YOY) revenue decline to RMB 946.05 million (USD 136.9 million) in H1 2022, with net losses of RMB 912.4 million (USD 132 million). R&D spending rose 12% YOY to RMB 1.06 billion (USD 153.6 million), while cash reserves stood at RMB…
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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…
