PharmaFocus Today – Page 2 – media

Zhonghong Medical’s subsidiary, Kelun Medical Devices, plans to be selected for multiple medical consumables procurement projects

On August 11, Zhonghong Medical(300981) issued an announcement that its holding subsidiary Jiangxi Kelun Medical EquipmentKelun Medical Devices recently participated in bidding for the seventh and eighth rounds of Jiangsu Province’s medical consumables procurement program, as well as Shaanxi Province’s centralized volume-based procurement program for indwelling catheters and foam dressings. Based on the winning results, some of Kelun Medical Devices’ products, including disposable vacuum blood collection tubes and indwelling catheters, are expected to be selected for these centralized volume-based procurement programs. The winning prices and quantities have not been disclosed. The sales revenue of Kelun Medical Equipment’s disposable vacuum blood collection tubes and indwelling needles in 2024 were RMB 6.53 million and RMB 3.94 million, respectively, accounting for 3.55% and 2.14% of its operating income in 2024, and also accounting for 0.27% and 0.16% of the company’s operating income in 2024, respectively. During the procurement cycle of the proposed selected ...
- Source: drugdu
- 30
- August 12, 2025
A new drug for fatal brain tumors receives accelerated approval from the FDA, giving China Resources Sanjiu a leading position in localization.

On August 6th, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Jazz Pharmaceuticals’ (Jazz Pharmaceuticals) oral drug, Dordaviprone (trade name: Modeyso). This is the world’s first targeted drug for diffuse midline glioma (DMG) with the H3 K27M mutation. It is indicated for patients aged one year and older who have failed first-line therapy. Because these aggressive brain tumors are located in surgically restricted areas such as the brainstem and spinal cord, traditional treatment relies solely on palliative radiotherapy, resulting in a median survival of only approximately 12 months. This approval breaks a 25-year stalemate in this field, which had been characterized by the lack of a systemic treatment. Image source: Jazz Pharmaceuticals official website During its development, the US biotechnology company Oncoceutics was the first to discover the molecule’s dual anti-cancer mechanism: inhibiting the RAS signaling pathway by blocking the tumor-promoting DRD2 receptor while simultaneously activating the ...
- Source: drugdu
- 30
- August 12, 2025
Yifan Pharmaceuticals files for first generic application for melatonin granules, aiming to seize the children’s sleep market

The CDE’s official website recently announced that the marketing application for melatonin granules from Suzhou Yifan Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Yifan Pharmaceutical, has been accepted. This Class 4 generic chemical drug, with 1g and 2mg dosages, targets sleep difficulties in Chinese children aged 6-15 with neurodevelopmental disorders. Melatonin, an endogenous hormone that regulates sleep-wake cycles, has clear clinical value in the treatment of childhood neurodevelopmental disorders. However, as of August 2025, only imported, originator-developed melatonin granules had been approved for marketing in China. Yifan Pharmaceuticals has applied for marketing authorization under the Class 4 chemical drug registration classification, becoming the first company in China to do so. There are a large number of children with neurodevelopmental disorders, including those with autism spectrum disorders and attention deficit hyperactivity disorder. Among these children, up to 50%-80% have sleep problems, of which difficulty falling asleep is the most common. Unlike ...
- Source: drugdu
- 30
- August 12, 2025
CureVac reaches settlement with BioNTech, Pfizer over COVID-19 vaccine patents

August 8, German biotechnology company CureVac announced on August 8 local time that CureVac and GlaxoSmithKline have partnered with BioNTech and Pfizer toAn agreement was reached to resolve and dismiss all outstanding patent lawsuits filed by several companies in the United States regarding mRNA-based COVID-19 vaccines, and to establish a framework for resolving ongoing patent disputes outside the United States. Under the terms of the agreement, CureVac and GlaxoSmithKline will receive a total of $740 million in payments and single-digit royalties on future sales of the COVID-19 vaccine in the United States. In addition, CureVac will receive $50 million in U.S. product royalties from GlaxoSmithKline. In addition, as part of the settlement, CureVac will grant BioNTech and Pfizer a non-exclusive license to produce, use, import and sell mRNA-based COVID-19 and/or influenza vaccines in the United States.This non-exclusive license will be expanded to a global license upon completion of BioNTech’s acquisition ...
- Source: drugdu
- 45
- August 9, 2025
New progress in AIDS vaccine research and development! Vaccines may usher in new opportunities

Recently, a research team including the AIDS Prevention and Control Center of the Chinese Center for Disease Control and Prevention completed the first phase I clinical trial of the Tiantan vaccinia vector HIV vaccine in China. This milestone progress has quickly ignited the development of biological vaccines.And market enthusiasm for related pharmaceutical sectors. With its mature technical route, the vaccine has successfully obtained complete Phase I clinical trial data, laying a solid foundation for breakthroughs in AIDS vaccine research and development, marking an important progress in my country’s vaccine innovation field and injecting strong momentum into the medical innovation track. Against this backdrop, the pharmaceutical innovation sector continues to garner market attention, with positive factors accumulating. The Hang Seng Pharmaceutical ETF (159892) and the Biotech ETF (516500), which cover leading biopharmaceutical vaccine companies, are expected to capitalize on this wave of industry innovation and become a valuable tool for investors ...
- Source: drugdu
- 44
- August 9, 2025
Bio-thera receives approval for clinical trials of BAT1308 and other drugs

On August 7, Bio-Thera(688177) issued an announcement that the company recently received the “Notice of Approval for Drug Clinical Trial” approved and issued by the National Medical Products Administration, approving the clinical trial application for BAT1308 injection combined with BAT4706 injection and BAT8008 injection for the treatment of advanced solid tumors. According to the announcement, BAT1308 injection is a humanized anti-PD-1 monoclonal antibody independently developed by the company, BAT4706 injection is an optimized IgG1 fully human monoclonal antibody targeting CTLA-4, and BAT8008 is an antibody-drug conjugate (ADC) targeting Trop2. The announcement stated that BAT1308 Injection, BAT4706 Injection, and BAT8008 Injection all met the relevant drug registration requirements and were approved for clinical trials. According to relevant data, Phase I/II clinical trials for anti-cancer drugs typically last approximately two years. The rate of progression from Phase I completion to Phase II is approximately 48.8%, while the rate of progression from Phase ...
- Source: drugdu
- 41
- August 9, 2025
FDA approves Tongxin Medical’s BrioVAD to enter confirmatory clinical study

August 7, BrioHealth Solutions, Inc., a wholly-owned subsidiary of Tongxin Medical in the United States, announced that its independently developed fully magnetically levitated left ventricular assist system, BrioVAD, has been officially approved by the U.S. Food and Drug Administration (FDA) to enter the Pivotal Phase study after successfully completing the Safety Phase of the U.S. INNOVATE clinical trial. The FDA agreed to expand the clinical research centers to 60 and can enroll a total of 780 subjects (including safety phase subjects). https://finance.eastmoney.com/a/202508073478544210.html
- Source: drugdu
- 42
- August 9, 2025
Fosun Pharma’s HLX43 for injection receives approval from the U.S. FDA for clinical trials

On the evening of August 7, Fosun Pharma (600196) announced that its controlling subsidiary, Shanghai Henlius Biotech Co., Ltd., and its subsidiaries (collectively, ” Henlius “), have received approval from the U.S. Food and Drug Administration (FDA) to conduct a Phase I clinical trial of HLX43 for injection (a PD-L1-targeting antibody-drug conjugate) for the treatment of thymic carcinoma (TC). Henlius plans to conduct a global, multicenter clinical study for this indication in Australia, Japan, the United States, and other locations once conditions permit. The announcement shows that the new drug is an antibody-drug conjugate (ADC) targeting PD-L1, developed by Henlius by conjugating a new DNA topoisomerase I inhibitor small molecule toxin-peptide linker licensed by Henlius with an antibody targeting PD-L1 independently developed by Henlius. It is intended for the treatment of advanced/metastatic solid tumors. https://finance.eastmoney.com/a/202508073478916056.html
- Source: drugdu
- 41
- August 9, 2025
Haisco has been approved to conduct clinical trials of its independently developed HSK47388 tablets

August 7, Haisco(002653) issued an announcement that the company recently received the “Notice of Approval for Drug Clinical Trial” issued by the National Medical Products Administration, approving its independently developed innovative drugClinical trials are underway for HSK47388 tablets, a Class 1 chemical drug intended for the treatment of autoimmune diseases. According to the announcement, HSK47388 tablets demonstrated dose-dependent inhibition of inflammatory responses in preclinical studies, with good tolerability and safety, and are expected to provide a new treatment option for patients with autoimmune diseases. The company will continue to monitor the progress of this project and fulfill its corresponding information disclosure obligations. In the first quarter of 2025, Haisco achieved revenue of 892 million yuan and net profit attributable to shareholders of the parent company of 46.61 million yuan. https://finance.eastmoney.com/a/202508073478877223.html
- Source: drugdu
- 37
- August 9, 2025
Sino Biopharmaceutical’s Rovaxin tablets included in the breakthrough therapy program

On August 6, Sino Biopharmaceutical Co., Ltd. issued an announcement stating that the group’s independently developed rovacitinib tablets “TQ05105 (JAK/ROCK inhibitor)” have been included in the Breakthrough Therapy Drug Program (BTD) by the Drug Review Center of the China National Medical Products Administration (CDE) for the treatment of chronic graft-versus-host disease (cGVHD). This event indicates that the drug has significant advantages in treating chronic graft-versus-host disease and is expected to accelerate its approval and marketing. This will enhance the company’s future performance expectations, strengthen investor confidence, and further enhance the company’s competitiveness and valuation in the capital market. https://finance.eastmoney.com/a/202508063477733776.html
- Source: drugdu
- 38
- August 9, 2025

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