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Allist Pharmaceuticals’ Furmonertinib Receives NMPA Approval for Two Clinical Trials
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Shanghai-based Allist Pharmaceuticals Inc. (SHA: 688578) has announced two clinical trial approvals from the National Medical Products Administration (NMPA) for its drug furmonertinib, a third-generation epidermal growth factor receptor (EGFR) inhibitor. The approvals allow for the initiation of a clinical study as a first-line treatment for exon 20 insertion mutated…
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Everest Medicines’ Nefecon NDA Accepted for Review by Singapore’s HSA
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China-based Everest Medicines (HKG: 1952) has announced that the Health Sciences Authority (HSA) of Singapore has accepted for review the New Drug Application (NDA) for its Nefecon (targeted-release formulation-budesonide) for adult patients with IgA nephropathy at risk of disease progression. The drug is anticipated to receive approval within the year.…
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Hutchison China Meditech Initiates Two Phase II Studies for HMPL-453 and Orpathys
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China-based Hutchison China Meditech (HutchMed, NASDAQ: HCM, HKG: 0013) has announced that the first subjects have been dosed in two separate Phase II regulatory studies. The first study is for the pipeline candidate HMPL-453, which is being assessed as a treatment for advanced intrahepatic cholangiocarcinoma with fibroblast growth factor receptor…
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Evopoint Biosciences Partners with Merck for Phase Ib/II Study Combining XNW5004 and Keytruda
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China-based Evopoint Biosciences has announced a collaboration agreement with US major Merck Sharp & Dohme (MSD, NYSE: MRK). The agreement will permit Evopoint to conduct a Phase Ib/II clinical study assessing the combination of the EZH2 inhibitor XNW5004 with MSD’s anti-PD-1 drug Keytruda (pembrolizumab) in advanced solid tumors. XNW5004: A…
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AstraZeneca and HKSTP Expand Collaboration with MoU to Support Start-Ups
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UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) and Hong Kong Science and Technology Parks Corp. (HKSTP) have signed a memorandum of understanding (MoU) to strengthen their existing collaboration. This deal builds upon an earlier collaboration signed in February 2021 and will see AstraZeneca and HKSTP supporting and providing services to…
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CStone Pharmaceuticals’ Sugemalimab Files for New Indication with NMPA for Esophageal Cancer
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China-based CStone Pharmaceuticals (HKG: 2616) has announced that the National Medical Products Administration (NMPA) has accepted for review another indication approval filing for its programmed death-ligand 1 (PD-L1) antibody, sugemalimab. The drug is proposed as a treatment for first-line unresectable, locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).…
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Biosion Receives FDA Approval for Phase II Study of TSLP mAb BSI-045B
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Global, clinical-stage biotech company Biosion, dedicated to developing antibody-based therapies for immune and oncologic diseases, has announced receiving approval from the US Food and Drug Administration (FDA) to initiate a Phase II clinical study for its thymic stromal lymphopoietin (TSLP) monoclonal antibody (mAb) BSI-045B. The in-house developed BSI-045B is intended…
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Shanghai Best-Link Bioscience Secures $29 Million in Series A Financing for Nano Drug Innovation
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Shanghai Best-Link Bioscience, LLC, a leading nano drug and drug delivery-focused enterprise based in Shanghai, has reportedly raised close to RMB 200 million (USD 29 million) in a Series A financing round. The funding round was led by Lapam Capital, with significant contributions from Hui Ding Capital and TigerYeah Capital.…
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OncoSec Medical’s TAVO-EP Combo Misses Primary Endpoint in Melanoma Trial
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US-based OncoSec Medical Inc., (OTCMKTS: ONCSQ), majority-owned by China-based Grand Pharmaceutical Group Ltd (HKG: 0512), has revealed disappointing data from a crucial pivotal Phase II trial assessing the firm’s lead DNA drug candidate TAVO-EP (tavokinogene telseplasmid) combined with the programmed death-1 (PD-1) monoclonal antibody Keytruda (pembrolizumab) as a treatment for…
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Legend Biotech Corporation Appoints Industry Veterans to Strategic Advisory Board
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China-based Legend Biotech Corporation (NASDAQ: LEGN) has announced the formation of a strategic advisory board and the appointments of Michel Vounatsos, former CEO of Biogen Inc., and John Maraganore, PhD, former CEO of Alnylam Pharmaceuticals, as advisors. Mr. Vounatsos and Dr. Maraganore will collaborate closely with Legend Biotech’s leadership team…
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Jacobio Pharma Receives Approval for Phase I/IIa Study of LIF mAb in Advanced Solid Tumors
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China-based Jacobio Pharma (HKG: 1167) has announced receiving approval in China to conduct a Phase I/IIa clinical study for its leukemia inhibitory factor (LIF) monoclonal antibody (mAb) in patients with advanced solid tumors. LIF as a Target for KRAS-driven TumorsLIF is a key target in KRAS-driven tumors, including pancreatic and…
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Nanjing Zenshine Pharmaceuticals’ ZX-7101A Meets Primary Endpoint in Phase II Influenza Study
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China-based small molecule drug developer Nanjing Zenshine Pharmaceuticals Co., Ltd announced that a Phase II clinical study for its anti-influenza drug ZX-7101A in adult simple influenza has successfully reached the primary endpoint. Design and Results of the Phase II/III StudyThe multi-center, randomized, double-blind, placebo-controlled Phase II/III study is designed to…
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WuXi Advanced Therapies (WuXi ATU) Closes Manufacturing Facilities in Shanghai Due to Market Changes
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Media reports indicate that WuXi Advanced Therapies (WuXi ATU), the gene and cell therapy-focused Contract Testing, Development, and Manufacturing Organization (CTDMO) unit of Wuxi Apptec (SHA: 603259, HKG: 2359), has closed its commercial-scale manufacturing facilities in Lingang, Shanghai. This decision was made in light of changing external market conditions, as…
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Shenzhen Hepalink’s Subsidiary Techdow USA Secures Distribution Rights for ANDA-Approved Drug
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China-based Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399) has announced that its wholly owned subsidiary, Techdow USA Inc., has entered into a distribution and supply agreement with compatriot firm Chia Tai Tianqing. The agreement centers on Chia Tai Tianqing’s ANDA-approved fosaprepitant dimeglutide in the United States, with Techdow being…
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SPH CanSinoBio Suspends COVID-19 Vaccine Production for 180 Days Amid Market Shifts
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SPH CanSinoBio, a joint venture between Shanghai Pharmaceuticals Group (SHA: 601607, HKG: 2607) and CanSino Biologics (SHA: 688185, HKG: 6185), has reportedly decided to halt production of COVID-19 vaccines as of April 4 for a period of 180 days, citing changes in the external market environment. The company, which is…
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CNBG and Sinopharm Form Partnership to Integrate Medical Industries
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China National Biotec Group Company Ltd (CNBG) has announced a strategic partnership with its parent company, Sinopharm. The collaboration aims to advance the integration of the “medical science, medical industry, and medical business” industries and to explore a high-quality sustainable development model that encompasses the entire industrial chain and ecosystem.…
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Beijing’s Surgerii Secures Series C3 Financing to Advance Endoscopic Surgical Robot Technology
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Beijing-based endoscopic surgical robot developer, Beijing Surgerii Robotics Company Limited, has reportedly raised hundreds of millions of renminbi in a Series C3 financing round. The round was led by Loyal Valley Capital, with participation from other investors including V Star Capital, SDIC, DNV Capital, and Sunart Investment. Investment to Drive…
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Lynk Pharmaceuticals Concludes Phase I Study for JAK Inhibitor LNK01003 with Positive Results
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China-based Lynk Pharmaceuticals (Hangzhou) Co., Ltd has announced the successful conclusion of a Phase I clinical study for its Category 1 innovative drug candidate, LNK01003. The trial, which assessed the molecule in healthy volunteers, demonstrated a good safety profile, tolerability, and pharmacokinetics. Design and Outcomes of the Phase I StudyThe…
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BioNTech and Duality Biologics Ink Exclusive License Agreement for ADC Assets
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Germany-based BioNTech SE (NASDAQ: BNTX) and China-headquartered Duality Biologics (Suzhou) Co., Ltd have announced that they have entered into exclusive license and collaboration agreements focused on two of Duality’s antibody-drug conjugate (ADC) assets. BioNTech is set to acquire all development, manufacturing, and commercialization rights to these two assets globally, excluding…
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Willingmed Secures Series B Funding to Advance Clinical Infection Diagnostics
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Willingmed, a Beijing-based company specializing in molecular biology for clinical infection precision diagnosis, has reportedly secured hundreds of millions of renminbi in a Series B financing round. The round was led by Galaxy Capital, Haier Capital, and Hunan Hi-Tech Venture Capital Health & Elderly Care Fund. The funds raised will…
