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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…
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ConceMed Raises Pre-Series A Funding to Expand Digestive Endoscope Pipeline
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ConceMed, a Guangdong-based maker of digestive soft electronic endoscopes, has reportedly raised “tens of millions” of renminbi in a Pre-Series A financing round. The funding was led by Cowin Capital, with participation from the National Innovation Center for Advanced Medical Devices. The proceeds will be used to accelerate the company’s…
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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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WuXi Biologics CEO Outlines Growth Amid Global Challenges at J.P. Morgan Conference
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China-based WuXi Biologics (HKG: 2269) delivered a speech at the J.P. Morgan Healthcare Conference, where its chief executive officer (CEO) Chen Zhisheng outlined the company’s strategic direction and achievements. Despite negative global macroeconomic conditions and inclusion on the US unverified list, WuXi Biologics has maintained its business model and continued…
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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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ReLive Biotechnologies Acquires Co.Don AG, Secures USD 36 Million for Expansion
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Tissue engineering and regenerative medicine start-up ReLive Biotechnologies Ltd has announced the full acquisition of Germany-listed Co.Don AG (FRA: CNW), gaining rights to its cartilage repair cell therapy Spherox/Chondrosphere. The move comes as the Hong Kong-based company secured over USD 36 million in a Series A financing round led by…
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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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JHM Biopharma Raises RMB100 Million to Expand Protein Drug Pipeline
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Hangzhou-based protein drug developer JHM Biopharma has reportedly secured close to RMB100 million (USD14.9 million) in a Series A+ financing round. The funding was led by 3E Bioventures and Guangdian Capital. Proceeds from the round will be allocated towards the development and expansion of JHM Biopharma’s product pipeline, as well…
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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…
