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Orion Holdings to Build Jining Vaccine Plant in China’s Shandong Province
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South Korea-based conglomerate Orion Holdings Corp. will enter China’s vaccine market by constructing a manufacturing plant in Jining city, Shandong Province. The company signed an agreement with local authorities this week to build a 49,600-square-meter biotechnology complex, with an investment of KRW90 billion ($69 million), set to begin operations by…
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Hangzhou DAC Biotech Doses First Patient in DXC007 AML Study
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China-based Hangzhou DAC Biotech Co., Ltd announced the first patient enrollment and dosing in a Phase I clinical study of its antibody drug conjugate (ADC) DXC007 for relapsed/refractory (r/r) acute myeloid leukemia (AML). The open, multi-center, dosage escalation and expansion trial will assess the drug’s safety, tolerability, and pharmacokinetics. Drug…
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Shanghai Ark Bio Raises Series D Funding to Advance Pediatric and Respiratory Drug Pipeline
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China-based Shanghai Ark Biopharmaceutical Co., Ltd has completed a Series D financing round, following its Series C round in January 2021. The latest round was led by Loyal Valley Capital and included participation from C&D Emerging Industry Equity Investment, Longda Foods, and existing investors such as Oriza Holdings, Qiming Venture…
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Simcere’s Trilaciclib Wins NMPA Approval for Chemotherapy Myeloprotection
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Jiangsu Simcere Pharmaceutical Co., Ltd’s trilaciclib has received marketing approval from the National Medical Products Administration (NMPA) for reducing chemotherapy-induced myelosuppression (CIM) in adult patients with extensive-stage small cell lung cancer (ES-SCLC). The drug, licensed from US biotech G1 Therapeutics, was approved under a prioritized review process. Drug ProfileTrilaciclib, a…
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Sinopharm Biotec and Ganzhou Government Partner on Medical Testing and Biotech R&D
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Sinopharm China National Biotec Group Co., Ltd (CNBG) announced a strategic partnership with the government of Ganzhou, Jiangxi Province, to collaborate on medical testing, research and development of innovative pet drugs, and the production of blood products. Partnership DetailsThe agreement will see CNBG and Ganzhou work together in multiple biomedical…
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Basecare Medical and Haier Biomedical Partner on IVF Cryopreservation Tech
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China-based IVF specialist Suzhou Basecare Medical Co., Ltd (HKG: 2170) announced a strategic partnership with compatriot firm Haier Biomedical Co., Ltd to collaborate on research and development in assisted reproductive cryogenic preservation. Financial terms of the agreement were not disclosed. Partnership FocusThe partnership aims to advance technologies in cryopreservation for…
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Huadong Medicine’s Biosimilar Victoza (Liraglutide) Accepted for NMPA Review
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its market filing for a biosimilar version of Novo Nordisk’s Victoza (liraglutide), produced by subsidiary Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd, has been accepted by the National Medical Products Administration (NMPA). The drug is intended as an adjunctive therapy for adult…
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CorrectSequence Therapeutics’ tBE Tech Wins USPTO Patent for Gene Editing
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Shanghai-based gene editing firm CorrectSequence Therapeutics announced it has received a patent from the United States Patent and Trademark Office (USPTO) for its variant base editing (tBE) system, a technology designed to enhance precision and reduce off-target mutations in gene editing. Technology HighlightsThe tBE system integrates a deoxycytidine deaminase inhibitor…
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Zai Lab’s Efgartigimod NDA Accepted by NMPA for Myasthenia Gravis
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Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) announced that the National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for efgartigimod, the world’s first FcRn antagonist, targeting generalized myasthenia gravis (MG). Drug ProfileEfgartigimod, developed by Netherlands-based Argenx and licensed to Zai Lab in January 2024 for up…
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Overland ADCT BioPharma Doses First Patient in Zynlonta’s Phase III LOTIS-5 Study for DLBCL
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Overland ADCT BioPharma (CY) Ltd, a joint venture between China’s Overland Pharmaceuticals and Switzerland’s ADC Therapeutics SA (NYSE: ADCT), announced the first patient dosing in the Phase III confirmatory LOTIS-5 study of Zynlonta (loncastuximab tesirine) for diffuse large B-cell lymphoma (DLBCL). The trial will evaluate the drug’s efficacy and safety…
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Triastek Partners with Eli Lilly to Explore 3D Printing for GI Drug Delivery
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China-based Triastek Inc., a pharmaceutical 3D printing specialist, announced a partnership with US firm Eli Lilly & Co. (NYSE: LLY) to explore 3D printing technology for precise, programmed drug release in the gastrointestinal (GI) tract. Partnership GoalsThe collaboration will focus on two key areas: Triastek’s Technology PlatformTriastek utilizes its MED…
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Zhejiang Medicine’s ARX305 ADC Receives Clinical Trial Approval for CD70-Positive Cancers
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China-based Zhejiang Medicine Co., Ltd (SHA: 600216) announced that its subsidiary NovoCodex Biopharmaceuticals Ltd has received approval to conduct a clinical study of ARX305, a Category 1 biologic drug targeting CD70 and AS269, for advanced tumors. The drug is designed to treat CD70-positive cancers, including renal cell carcinoma and multiple…
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GenScript ProBio Partners with ACT Therapeutics on CAR-T Cell Therapy Development
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GenScript ProBio, a global Contract Development and Manufacturing Organization (CDMO), announced a memorandum of understanding (MOU) with South Korea’s ACT Therapeutics to collaborate on cell therapy development. GenScript will act as ACT’s global partner, providing plasmid and virus vector services to advance ACT’s chimeric antigen receptor (CAR) T cell therapy…
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Abbisko Therapeutics’ ABSK021 Receives BTD for Giant Cell Tumor Treatment
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Shanghai-based Abbisko Therapeutics Co., Ltd (HKG: 2256) announced that its Category 1 drug ABSK021 has received breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) for treating inoperable giant cell tumor of tendon sheath. The drug, a CSF-1R inhibitor, is being developed for both tumor and non-tumor indications.…
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HutchMed’s Orpathys-Tagrisso Combo Shows Promise in NSCLC at WCLC
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China-based HutchMed (NASDAQ: HCM, HKG: 0013) announced the publication of an abstract detailing the SAVANNAH Phase II trial results at the World Conference of Lung Cancer (WCLC). The study evaluates the combination of HutchMed’s Orpathys (savolitinib) and AstraZeneca’s Tagrisso (osimertinib) in EGFR-mutated, MET-driven non-small cell lung cancer (NSCLC) patients with…
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Junshi Biosciences’ JS203 Bispecific Antibody Receives NMPA Green Light for NHL Study
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) announced that the National Medical Products Administration (NMPA) has approved its injectable bispecific antibody (BsAb) JS203 for a clinical study in relapsed or refractory B-cell non-Hodgkin lymphoma (NHL). The drug targets CD20 and CD3, leveraging these antigens to enhance tumor-inhibiting effects. Drug Profile…
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CDE Grants Priority Review to Ascentage’s Olerembatinib and Roche’s Crovalimab
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The Center for Drug Evaluation (CDE) has granted priority review status to two drugs: Suzhou Ascentage Pharma’s olverembatinib and Roche’s crovalimab. The designations aim to accelerate regulatory timelines for these therapies targeting unmet medical needs. Ascentage’s Olerembatinib Roche’s Crovalimab
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Athenex Sells China Subsidiaries to TiHe Capital for USD 19 Million
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US-based Athenex Inc. (Nasdaq: ATNX) announced an agreement to sell all equity interests in its China-based subsidiaries, primarily involved in active pharmaceutical ingredient (API) manufacturing, to China’s TiHe Capital (Beijing) Co., Ltd for RMB 124.4 million ($19 million). The deal, subject to customary closing conditions, will see Athenex receive ~70%…
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Tasly Pharmaceuticals and Mauna Kea Form JV to Commercialize Cellvizio in China
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China-based Tasly Pharmaceuticals (SHA: 600535) announced a joint venture (JV) with France’s Mauna Kea Technologies (Paris: MKEA) to commercialize the Cellvizio platform in China and develop it globally for neurology and neurosurgery. The JV will hold exclusive rights to Cellvizio for certain indications in China and global rights for neurological…
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MicroPort MedBot’s Honghu Robot Wins FDA 510(k) Certification for Joint Replacement
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Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252) announced that its in-house developed orthopedic surgery robot Honghu has received 510(k) certification from the US FDA, marking it as the first and only home-grown surgical robot approved in the US. Product HighlightsDesigned for joint replacement surgery, the Honghu robot offers accurate,…
