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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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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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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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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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Luye Pharma’s Rykindo Receives FDA Approval for Schizophrenia and Bipolar I Disorder
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China-based Luye Pharma Group (HKG: 2186) has announced receiving market approval from the US Food and Drug Administration (FDA) for its extended-release injectable suspension Rykindo (risperidone). The drug is approved for the treatment of schizophrenia in adults and as a monotherapy or adjunctive therapy to lithium or valproate for the…
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Hengrui’s Generic Cyclophosphamide Capsules Approved by China’s NMPA
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China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its generic version of cyclophosphamide, marketed as Endoxan by UK firm Hikma Pharmaceuticals USA Inc. The approval allows Hengrui to market its capsules for the treatment of a wide range of…
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Akeso’s Penpulimab Secures New Approval for Lung Cancer Indication
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China-based Akeso Biopharma (HKG: 9926) has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its PD-1 inhibitor penpulimab (AK105). The drug is now approved for the treatment of first-line or locally advanced/metastatic squamous non-small cell lung cancer (sqNSCLC) in combination with chemotherapy. This marks a…
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Clover Biopharmaceuticals Plans COVID-19 Vaccine SCB-2019 Launch in China for 2023
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China-based Clover Biopharmaceuticals, Ltd (HKG: 2197) has provided updates on its plans for the commercialization of its COVID-19 vaccine SCB-2019 (CpG 1018/Alum) in China, with a strategic focus on 2023. The company expects to begin the commercial launch of SCB-2019 in multiple provinces and municipalities in China during the first…
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Sino Biopharma’s PD-L1 Combo with Anlotinib Accepted for Review by China’s CDE
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China-based Sino Biopharmaceutical Ltd (HKG: 1177) has announced that its New Drug Application (NDA) filing for the combination of its anti-PD-L1 monoclonal antibody (mAb) TQB2450 and anlotinib has been accepted for review by the Center for Drug Evaluation (CDE). The Phase III study for this combination in first-line small cell…
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Guangzhou’s Overseas Pharma Wins China Clinical Trial Approval for OPL-038
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Guangzhou-based Overseas Pharmaceuticals, Ltd has secured clinical trial approval in China for its sustained and controlled release drug OPL-038. The drug, filed as an Investigational New Drug (IND) under Category 2 (modified drug), aims to address the needs of adult patients with type 2 diabetes through a novel combination therapy.…
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Xinhua Pharma’s OAB-14 Receives NMPA Approval for Phase I Alzheimer’s Study
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China-based Shandong Xinhua Pharmaceutical Co., Ltd (SHE: 000756) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study of its innovative Alzheimer’s disease (AD) drug, OAB-14. The study will assess the safety and tolerability, pharmacokinetics, pharmacodynamics, and food effects of OAB-14 in…
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Konruns’ KC1036 Advances to Phase II Study for Lung Adenocarcinoma
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Beijing-based Konruns Pharmaceutical Co., Ltd (SHA: 603590) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study of its Category 1 chemical drug KC1036. The study will assess the efficacy and safety of KC1036 in combination with docetaxel for the treatment of…
