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CSPC Pharmaceutical’s mRNA Vaccine SYS6006 Receives Emergency Use Authorization in China
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has obtained an Emergency Use Authorization (EUA) for its in-house developed COVID-19 mRNA vaccine, SYS6006, in China. This approval marks a significant milestone as it is the first for a domestically developed mRNA product in the country. Design and…
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Boston Scientific Launches Athletis Peripheral Balloon Dilatation Catheter in China
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US-based medical device leader, Boston Scientific Corporation (NYSE: BSX), has announced the market launch of its Athletis peripheral balloon dilatation catheter in mainland China. The product is designed for percutaneous transluminal angioplasty (PTA) of the peripheral vascular system and is utilized in the treatment of stenotic lesions in autologous or…
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CDE Launches Technical Guidelines for Pediatric Anti-tumor Drug Development
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The Center for Drug Evaluation (CDE) has released a set of Technical Guidelines focused on “Clinical R&D of Anti-tumor Drugs for Children,” which are now in immediate effect. These guidelines were drafted in response to the need for more targeted research and development efforts for pediatric anti-tumor drugs, an area…
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Huarun Pharmaceutical Co., Ltd Announces Private Placement to Fund Expansion and R&D
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China-based Huaren Pharmaceutical Co., Ltd (SHE: 300110) is set to raise capital through the private placement of 355 million shares, aiming to collect RMB 1.34 billion (USD 194.8 million). The funds procured will be allocated towards several key projects, including the expansion of peritoneal dialysate production capacity, the construction of…
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CDE Issues New Guidance on Pre-Phase III Clinical Trial Meetings for Innovative Drugs
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The Center for Drug Evaluation (CDE) has released the “Innovative Chemical Drug Pre-Phase III Clinical Trial Meeting, Common Issues and Related Technical Requirements,” with the guidance taking immediate effect. This document is designed to streamline the communication process between pharmaceutical companies and the CDE during the clinical development phase of…
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Zhaoke Ophthalmology Signs Distribution Agreement with Kwangdong for NVK002 in South Korea
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China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622) has announced a distribution and supply agreement with South Korea’s Kwangdong Pharmaceutical Co., Ltd for NVK002, an atropine external use eye solution. Under the terms of the agreement, Kwangdong will assume import, publicity, distribution, marketing, and sales…
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Sihuan Pharmaceutical’s XZP-KM602 and XZP-6877 Gain Clinical Trial Approvals
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China-based Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has announced that its minority-owned subsidiary, Xuanzhu Biopharmaceutical Co., Ltd, has obtained clinical trial approvals for two in-house developed drugs: CD80 mutant Fc fusion protein XZP-KM602 and DNA dependent protein kinase (DNA-PK) inhibitor XZP-6877. Both drugs are aimed at treating advanced solid…
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YHLO Biotech Partners with NCRCID to Develop Advanced Tuberculosis Diagnostics
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China-based Shenzhen YHLO Biotech Co., Ltd has entered into a strategic partnership with the National Clinical Research Center for Infectious Diseases (NCRCID) to develop advanced tuberculosis diagnosis products. The collaboration aims to enhance diagnostic capabilities for tuberculosis, a critical area of focus for both organizations. No financial details were disclosed…
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Everest Medicines Receives $280 Million from Gilead’s Immunomedics Following Partnership Cancellation
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China-based Everest Medicines (HKG: 1952) has announced a significant financial development, receiving a full upfront payment of USD 280 million from Immunomedics, Inc., now a wholly-owned subsidiary of Gilead Sciences, Inc (NASDAQ: GILD). This payment is in relation to the cancellation of a partnership established in 2019, which was focused…
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Akeso Biopharma and LaNova Medicines Collaborate on Clinical Studies for Cancer Therapies
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China-based Akeso Biopharma (HKG: 9926) has announced a strategic partnership with fellow Chinese firm LaNova Medicines to advance a series of clinical studies. The collaboration will assess a combination regimen of Akeso’s AK112, a bispecific antibody (BsAb) targeting programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF), with LaNova’s LM-302,…
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Lee’s Pharmaceutical Subsidiary Secures Distribution Deal for NVK002 in South Korea
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China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), through its subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622), has announced a distribution and supply agreement with South Korea-based Kwangdong Pharmaceutical Co., Ltd (KRX: 009290) for NVK002, an atropine external use eye solution. Agreement Details and Financial TermsAccording to the agreement, Kwangdong will handle…
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Sihuan Pharmaceutical’s XZP-KM602 and XZP-6877 Secure Clinical Trial Approvals for Solid Tumors
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China-based Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has announced that its minority-owned subsidiary, Xuanzhu Biopharmaceutical Co., Ltd, has obtained clinical trial approvals for two in-house developed drugs: CD80 mutant Fc fusion protein XZP-KM602 and DNA dependent protein kinase (DNA-PK) inhibitor XZP-6877. Both drugs are aimed at treating advanced solid…
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Shenzhen YHLO Biotech Partners with NCRCID for Advanced Tuberculosis Diagnostics
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China-based Shenzhen YHLO Biotech Co., Ltd has announced a strategic partnership with the National Clinical Research Center for Infectious Diseases (NCRCID) to develop advanced tuberculosis diagnosis products. The collaboration aims to leverage both entities’ expertise to enhance diagnostics in the field of infectious diseases, with a focus on tuberculosis. Financial…
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Everest Medicines Receives $280 Million from Gilead Sciences for Partnership Cancellation
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China-based Everest Medicines (HKG: 1952) has announced that it has received a full upfront payment of USD 280 million from Immunomedics, Inc., now a wholly-owned subsidiary of Gilead Sciences, Inc (NASDAQ: GILD). This payment is in relation to the cancellation of a previous 2019 partnership between the two firms, which…
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Akeso Biopharma and LaNova Medicines Collaborate on AK112 and LM-302 Combo for Solid Tumors
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China-based Akeso Biopharma (HKG: 9926) has entered into a strategic partnership with compatriot firm LaNova Medicines to advance a series of clinical studies. These studies will assess the combination regimen of Akeso’s AK112, a bispecific antibody (BsAb) targeting programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF), alongside LaNova’s LM-302,…
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CSPC Pharmaceutical’s mRNA Vaccine SYS6006 Receives Emergency Use Authorization in China
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has revealed that it has obtained an Emergency Use Authorization (EUA) for its in-house developed COVID-19 mRNA vaccine, SYS6006, in China. This approval marks a significant milestone as it is the first for a domestically developed mRNA product in the country. SYS6006 Design…
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CDE Launches Technical Guidelines for Pediatric Anti-tumor Drug Clinical R&D
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The Center for Drug Evaluation (CDE) has released a set of Technical Guidelines focused on “Clinical R&D of Anti-tumor Drugs for Children,” which are now in immediate effect. These guidelines were drafted to address the specific needs and considerations in the development of anti-tumor drugs for pediatric patients. Public Consultation…
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Huarun Pharmaceutical Co., Ltd Announces Private Placement to Fund Expansion Projects
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China-based Huaren Pharmaceutical Co., Ltd is set to raise RMB 1.34 billion (USD 194.8 million) through a private placement of 355 million shares. The funds raised will be allocated towards several key projects, including the expansion of peritoneal dialysate production capacity, construction of a drug packaging material production base, development…
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CDE Releases Guidance on Pre-Phase III Clinical Trial Meetings for Innovative Chemical Drugs
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The Center for Drug Evaluation (CDE) has released the “Innovative Chemical Drug Pre-Phase III Clinical Trial Meeting, Common Issues and Related Technical Requirements,” a document that takes immediate effect. This guidance aims to streamline the clinical development process by providing clarity on the common issues and general requirements of pre-Phase…
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Everest Medicines Partners with Guangdong Provincial People’s Hospital in Kidney Disease Research
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China-based Everest Medicines Ltd (HKG: 1952) has announced a comprehensive strategic partnership with Guangdong Provincial People’s Hospital in the field of kidney disease. The collaboration aims to advance research and development in this critical area of healthcare. No financial details were disclosed in the partnership agreement. Everest’s Pipeline in Kidney…
