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Junshi Biosciences’ COVID-19 Drug JT001 (VV116) Accepted for NMPA Review
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has announced that its oral nucleoside analog drug JT001 (VV116) for treating COVID-19 has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step forward in the development and potential market approval of the drug in China.…
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Bristol-Myers Squibb’s Opdivo Gains New Indication for NSCLC Neoadjuvant Therapy in China
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US-based pharmaceutical giant Bristol-Myers Squibb (BMS, NYSE: BMY) has secured another indication approval in China for its PD-1 inhibitor Opdivo (nivolumab). The immunotherapy is now approved for use in combination with chemotherapy as neoadjuvant therapy for adult patients with resectable non-small cell lung cancer (NSCLC), regardless of PD-L1 expression levels.…
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Daiichi Sankyo’s Mirogabalin Nears China Market Entry with CDE Review
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Japan-based Daiichi Sankyo Inc. (TYO: 4568) has announced that China’s Center for Drug Evaluation (CDE) has accepted its market approval filing for mirogabalin besylate, a novel chronic pain treatment. The drug is specifically targeted at diabetic peripheral neuropathic pain (DPNP), a condition that affects a significant number of patients with…
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Bio-Thera’s Biosimilar BAT1806 Passes NMPA Review, Targets Roche’s Actemra
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China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that its biosimilar drug BAT1806, modeled after Roche Holding AG’s (OTCMKTS: RHHBY) blockbuster Actemra/RoActemra (tocilizumab), has successfully passed review by the National Medical Products Administration (NMPA). This milestone positions Bio-Thera to enter a market dominated by Roche’s originator drug, which has been…
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Abbisko’s ABSK021 Gains NMPA Approval for Phase II Study in cGVHD
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its Category 1 drug ABSK021 (pimicotinib) in chronic graft versus host disease (cGVHD). This marks a significant step forward in the development of…
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AffaMed Secures China Rights to Eli Lilly’s Migraine Drug Galcanezumab
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China-based AffaMed Therapeutics has announced an agreement with Eli Lilly and Company to obtain sole commercialization rights for galcanezumab in mainland China. The monoclonal antibody, developed by Eli Lilly, selectively binds to the calcitonin gene-related peptide (CGRP) and was approved by the FDA in September 2018 for the preventive treatment…
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China’s NHC Releases Second National Drug Use Monitoring List
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China’s National Health Commission (NHC) has released the second national drug use monitoring list, covering 30 drugs. Local bureaus are required to formulate and improve clinical application guidelines for these drugs, clarify the conditions and principles of clinical application, and strengthen the supervision of rational drug use. First List and…
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Suzhou Powersite Electric Secures Series B Funding for X-ray Imaging Expansion
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China-based X-ray imaging core component supplier Suzhou Powersite Electric Co., Ltd has reportedly raised hundreds of millions of renminbi in a Series B financing round. The round was led by Yuanbio Venture Capital, with contributions from Suzhou High-Tech Venture Capital, Medpark, Northern Light Venture Capital, Cross Currents Capital, and SND…
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Beijing Interbio Secures Pre-Series A Funding for SPR Technology Expansion
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Beijing Interbio Biology & Technology Co., Ltd, a China-based company specializing in surface plasmon resonance (SPR) technology and other life sciences testing instruments, has reportedly raised an undisclosed amount in a Pre-Series A financing round led by Jintan Capital. The proceeds will be used to support commercial equipment installation, mass…
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CStone’s RET Inhibitor Gavreto Approved in Taiwan for Lung and Thyroid Cancers
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CStone Pharmaceuticals (HKG: 2616) has announced receiving marketing approval in Taiwan for its RET inhibitor Gavreto (pralsetinib), a drug in-licensed from US-based biotech Blueprint Medicines in June 2018. The approval covers the treatment of adults with locally advanced or metastatic RET fusion-positive non-small cell lung cancer (NSCLC), advanced or metastatic…
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Ascletis Partners with Simcere for Ritonavir Supply in COVID-19 Drug Development
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced that its wholly-owned subsidiary Ascletis Pharmaceuticals Co., Ltd has entered into a supply agreement for ritonavir tablets with Hainan Simcere Pharmaceutical Co., Ltd, a subsidiary of Simcere Pharmaceutical Group Limited (HKG: 2096). This partnership aims to support the development and supply chain…
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Simcere’s COVID-19 Drug SIM0417 Accepted for Special Review by NMPA
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced that the National Medical Products Administration (NMPA) has accepted a New Drug Application (NDA) for SIM0417 into its special review channel. The oral COVID-19 drug candidate is co-developed with the Chinese Academy of Science’s Shanghai Institute of Materia Medica (SIMM) and the…
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Bristol-Myers Squibb’s Opdivo Secures Two New Approvals for Esophageal Cancer in China
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US-based pharmaceutical giant Bristol-Myers Squibb (BMS, NYSE: BMY) has received two new indication approvals in China for its PD-1 inhibitor Opdivo (nivolumab). The immunotherapy is now approved as adjuvant therapy for patients with pathological residual esophageal cancer or gastroesophageal junction cancer following neoadjuvant chemoradiotherapy (CRT) and complete surgical resection. Additionally,…
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Henlius’ PD-1 Inhibitor HanSiZhuang Approved for First-Line SCLC Indication
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Shanghai Henlius Pharmaceutical Co., Ltd (HKG: 2696) has announced receiving another indication approval from China’s National Medical Products Administration (NMPA) for its PD-1 inhibitor, HanSiZhuang (serplulimab). The drug is now approved for use in combination with chemotherapy as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC), marking the…
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Agilis Robotics Completes Successful Animal Testing for Surgical Robot
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Hong Kong-based Agilis Robotics Ltd has successfully completed a second round of live animal testing using its proprietary surgical robotic system. The test, conducted by Dr. Jason Y.K. Chan, co-founder of Agilis Robotics, utilized the company’s second-generation device to remove artificial tumors from a live pig specimen using the en-bloc…
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CARsgen and Huadong Medicine Partner to Commercialize BCMA CAR-T Product CT053 in China
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China-based CARsgen Therapeutics Holdings Limited (HKG: 2171), a leading developer of innovative CAR T-cell therapies, and Huadong Medicine (Hangzhou) Co., Ltd., a wholly-owned subsidiary of Huadong Medicine Co., Ltd (SHE: 000963), have announced a strategic collaboration to commercialize CARsgen’s BCMA CAR-T product, CT053, in mainland China. Under the agreement, CARsgen…
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Tongshu Gene Partners with LC Gene to Distribute Gene Mutation Detection Kit in China
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China-based gene testing service providers Tongshu Gene and LC Gene Diagnostics (Hangzhou) Co., Ltd. have entered into a strategic partnership, under which Tongshu Gene will become the exclusive distributor of LC Gene’s human EGFR, BRAF, KRAS, ALK, and ROS1 gene mutation detection kit. The agreement leverages LC Gene’s proprietary technology…
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3D Medicines’ 3D185 Receives Orphan Drug Designation for Gastric Cancer
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China-based oncology specialist 3D Medicines (HKG: 1244) has announced receiving orphan drug designation (ODD) status from the US Food and Drug Administration (FDA) for its pipeline drug candidate 3D185. The designation was granted for the drug’s potential use in treating gastric cancer and gastroesophageal junction carcinoma (GC/GEJ). This marks the…
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Ascletis Pharma Initiates Dosing in Phase I Trial for COVID-19 Treatment ASC11
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced the dosing of four healthy subjects in the first cohort of a multi-dose escalation Phase I clinical study for its oral 3-chymotrypsin-like protease (3CLpro) inhibitor ASC11, in combination with 100 mg ritonavir tablets. The study aims to evaluate the safety, tolerability, and…
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Base Therapeutics Secures Series A1 Funding to Advance Gene Editing Pipelines
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Base Therapeutics, a Guangdong-based firm specializing in base editing and prime editing technologies, has reportedly raised “tens of millions” of US dollars in a Series A1 financing round. The funding was led by Great Eagle VC, with participation from Baidu Venture, Sincere Capital, GDHT Capital, SPARK VC, and existing investor…
