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Biocytogen’s ‘Nano 100 Project’ Aims to Develop Over 100 Fully Human Nanobody Drugs
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China-based Biocytogen Pharmaceuticals (Beijing) Co., Ltd has announced the launch of the “Nano 100 Project,” an ambitious initiative designed to develop fully human nanobody drugs for over 100 targets. This project leverages Biocytogen’s proprietary fully human nanobody mouse, RenNano, in conjunction with its high-throughput in vitro and in vivo antibody…
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Biosyngen’s BRG01 Gets FDA Nod for NPC Clinical Study
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Cell and gene therapy (CGT) specialist Biosyngen Pte Ltd has announced receiving approval from the US FDA to initiate a Phase I/II clinical study for its BRG01, an autologous T cell therapy for the treatment of relapsed/metastatic nasopharyngeal cancer (NPC). This marks a significant milestone in the development of innovative…
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CDE Issues Guidelines for Real-World Drug Research and Evidence Framework
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The Center for Drug Evaluation (CDE) has released two important documents: the “Guiding Principles of Real-World Drug Research Design and Program Framework (trial)” and the “Guiding Principles of Communication and Exchange of Real-World Evidence Supporting Drug Registration Applications (trial).” These guidelines are designed to enhance the quality and efficiency of…
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China’s 8th Volume-Based Procurement Round Begins Drug Info Filing
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The national drug alliance procurement office has released a notification initiating the drug information filing process for the 8th volume-based procurement (VBP) round. This round is a significant step in the ongoing efforts to streamline and optimize the procurement of pharmaceuticals in China. Registration and Information SubmissionAs of February 20,…
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BRL Medicine Achieves First Cure of Thalassemia Major with BRL-101
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Shanghai-based BRL Medicine Inc. has announced a significant breakthrough in the treatment of thalassemia major. The company reported the first cure in a multi-center Phase clinical study assessing the safety and efficacy of its BRL-101, an autologous hematopoietic stem progenitor cell therapy. This marks a major milestone in the development…
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Immuno Cure BioTech Launches Phase I HIV/AIDS Vaccine Study
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China-based Immuno Cure BioTech has announced the initiation of a Phase I clinical study for its ICVAX, a therapeutic vaccine against HIV/AIDS, in Shenzhen. This marks a significant step forward in the development of innovative treatments for HIV/AIDS, a condition that affects millions of people globally. Study Design and ObjectivesThe…
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Clover Biopharmaceuticals Secures Exclusive Deal for AdimFlu-S Distribution in China
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China-based Clover Biopharmaceuticals, Ltd (HKG: 2197) has announced an exclusive agreement with Adimmune Corporation for the distribution of AdimFlu-S (QIS) in mainland China. AdimFlu-S (QIS) is the only imported quadrivalent seasonal influenza vaccine approved for use in individuals aged three years and older in China. The agreement also grants Clover…
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Hainan Honz Partners with GPI for Pediatric and Maternity Medicine Expansion
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China-based Hainan Honz Pharmaceutical Co., Ltd (SHE: 300086) has entered into a three-year partnership with Indonesia’s Global Putra International (GPI). The strategic collaboration is focused on multiple fronts, aiming to expand Hainan Honz’s pediatric and maternity medicines into overseas markets through the Regional Comprehensive Economic Partnership (RCEP) and Hainan free…
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MoleculeMind Raises Over RMB 100 Million for AI Protein Design Platform
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MoleculeMind, an artificial intelligence (AI)-empowered protein design platform based in Beijing, has reportedly raised over RMB 100 million (USD 14.58 million) in its latest financing round. The round was led by Cathay Biotech Inc. (SHA: 688065), a synthetic biology firm based in Shanghai, with contributions from Lenovo Capital and Sequoia…
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Zhejiang Suspends Generic Nesina Trading Due to IP Disputes
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Zhejiang’s Provincial Center for Drug & Medical Device Procurement has issued a notification suspending the online trading qualifications for generic versions of Takeda’s (TYO: 4502) Nesina (alogliptin). The notice specifically targets products manufactured by Jiangsu Zhongtian Pharmaceutical Co., Ltd and Sinopharm Guorui Pharmaceutical Co. Ltd. This suspension is part of…
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China’s 2022 Western Medicine Trade Analysis: Growth and Challenges
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The China Chamber of Commerce for Import and Export of Medicines and Health Products (CCCMHPIE) has released its “Brief Analysis of and Prospects for China’s Foreign Trade of Western Medicines in 2022.” The report covers the import and export of raw materials, western pharmaceutical preparations, and biochemical drugs, providing a…
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Wuhan Binhui’s Oncolytic Virus Therapy Awarded Breakthrough Designation by CDE
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The Center for Drug Evaluation (CDE) website indicates that China-based Wuhan Binhui Biotechnology Co., Ltd’s GM-CSF oncolytic herpes simplex virus type II (OH2) for injection (Vero cells) has been awarded breakthrough therapy designation (BTD) status. This designation is for the treatment of patients with unresectable or metastatic melanoma who have…
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CDE Awards Priority Review to Eisai’s Lecanemab for Early Alzheimer’s Disease
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The Center for Drug Evaluation (CDE) website indicates that Japan-based Eisai’s (TYO: 4523) lecanemab has been awarded priority review status. The drug falls under the category of “clinically urgent shortage drugs and innovative and modified drugs for the prevention and treatment of major infectious diseases and rare diseases.” This designation…
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Chunlizhengda to Acquire Majority Stake in Surgimaster for Medical Power Tools
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Beijing Chunlizhengda Medical Instruments Co., Ltd (HKG: 1858, SHA: 688236) is poised to acquire a 60.25% stake in Surgimaster Surgical Co., Ltd, a medical power tool products provider based in Suzhou. The transaction, valued at RMB 11 million (USD 1.6 million), is accompanied by an additional RMB 6.5 million (USD…
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Duoning Biotech Secures Global Rights to Junzhen’s Cell Counter Products
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China’s Shanghai Duoning Biotechnology Co., Ltd has entered into a licensing deal with compatriot firm BioAces (Shanghai) Life Science Co., Ltd., obtaining exclusive global rights to the latter’s cell counter products. The products in question include the CytScope PRO and CytScope MINI intelligent cell analyzers, both of which are already…
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Sansure Biotech Partners with Hunan Normal University for Research and Talent Development
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China-based molecular diagnostics specialist Sansure Biotech Inc. (SHA: 688289) has announced a strategic partnership with Hunan Normal University. The collaboration aims to leverage the respective strengths of both entities to delve deeper into talent cultivation, scientific research, and platform co-construction, among other areas. No financial details of the partnership were…
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Amcor Acquires Shanghai-Based MDK to Expand Asia-Pacific Footprint
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Switzerland-based packaging firm Amcor (NYSE: AMCR) has unveiled the signing of a deal to acquire Shanghai-based medical device packaging company MDK. The acquisition gives Amcor control of a company with approximately USD 50 million in annual revenues and adds a manufacturing site to strengthen its presence in the Asia-Pacific region.…
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CSPC’s NBL-020 Gets NMPA Approval for Clinical Study in Advanced Solid Tumors
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving the go-ahead from the National Medical Products Administration (NMPA) to initiate a clinical study for the antibody drug NBL-020. This marks a significant step forward in the development of new treatments for advanced solid tumors. NBL-020: Anti-Tumor Necrosis Factor Type…
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Kelun Pharma’s Generic Jardiance Gains New Indication in China
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China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has obtained another indication approval in China for its generic version of BI/Eli Lilly’s Jardiance (empagliflozin). The hypoglycemic agent can now be used to reduce the risk of hospitalization due to heart failure in adult patients with symptomatic chronic heart failure. Jardiance:…
