PharmaFocus Today – Page 135 – media

Two medical devices have entered the priority approval channel

According to the China Medical Device Innovation and Priority Approval Database, in December 2024, two medical devices entered the priority approval green channel in public announcements issued by local drug regulatory authorities across the country. They are: the disposable electronic endoscopic thoracoscopic laparoscopic catheter from Fujian Zhide Medical Technology Co., Ltd. (hereinafter referred to as Fujian Zhide), and the cognitive impairment assisted diagnosis and rehabilitation software from Hainan Boya Health Technology Co., Ltd. (hereinafter referred to as Hainan Boya). Fujian Zhide: Focusing on Endoscopy Fujian Zhide was established in April 2022 and is a company dedicated to the research and manufacturing of electronic endoscopic medical devices. The disposable 4K electronic endoscope technology developed by the research and design team of Fujian Zhide Optics has received widespread attention. This technology is both safe and convenient, not only greatly reducing the infection rate and improving cost-effectiveness, but also adapting to grassroots needs. ...
- Source: drugdu
- 234
- January 9, 2025
Innovent has made a good start

At the beginning of the new year, Innovent Biologics brought the first good news of going overseas. Recently, Innovent Biologics and Roche reached a global exclusive cooperation and licensing agreement on the new generation of DLL3 antibody-drug conjugates. Innovent Biologics granted Roche the exclusive rights to the global development, production and commercialization of IBI3009. The two parties will jointly be responsible for the early development of the ADC candidate drug, and Roche will be responsible for subsequent clinical development. Innovent Biologics will receive a total transaction amount of US$1.08 billion (including an initial payment of US$80 million and potential development and commercialization milestone payments of up to US$1 billion, as well as sales commissions). Just a few days ago, Hengrui Medicine also reached a licensing cooperation for DLL3 ADC drugs. Hengrui Medicine licensed the overseas rights of SHR-4849 to IDEAYA Biosciences of the United States for a total amount of ...
- Source: drugdu
- 285
- January 9, 2025
A battle for survival for BTK inhibitors?

Recently, Sanofi’s Rilzabrutinib was applied for listing in China for the treatment of immune thrombocytopenia (ITP). This means that the “six-strong competition” pattern in the domestic BTK inhibitor market has begun to emerge. The autoimmune BTK inhibitor market is now a place of chaos. Before Sanofi’s Rilzabrutinib was applied for listing, five BTK inhibitors had been approved in China, including AbbVie/Johnson & Johnson’s ibrutinib, AstraZeneca’s acotinib, BeiGene’s zanubrutinib, Innovent’s obeticholic steroids, and Eli Lilly’s Pirtobrutinib. The indications are mainly concentrated in hematological tumors, and only a few have been approved for autoimmune diseases. It can be seen that focusing on autoimmune indications has become a differentiated breakthrough path. Sanofi’s Rilzabrutinib is the embodiment of this strategy. The strong players in the autoimmune track are not only AbbVie and Johnson & Johnson, but also Sanofi’s strength should not be underestimated. For example, the ace product Dupixent (dupixentumab) is a “super blockbuster” ...
- Source: drugdu
- 574
- January 9, 2025
WuXi Biologics Plans to Sell Irish Vaccine Facility-Related Assets for $500 Million

On January 6, WuXi Biologics announced that the company, along with its indirect wholly-owned subsidiary WuXi Biologics Ireland, has entered into an agreement with MSD International to sell assets related to its Irish vaccine facility for $500 million. WuXi Biologics stated that the net proceeds from the asset sale will be used for the group’s operational development and general working capital for various regional operations, as well as for potential further share buybacks by the company. WuXi Biologics primarily provides comprehensive end-to-end vaccine CDMO services and acts as a global biopharmaceutical CRDMO, offering end-to-end solutions for biopharmaceutical discovery, development, and production for clients in the biopharmaceutical industry. MSD International is a subsidiary of a global pharmaceutical company that provides innovative health solutions through its prescription medicines, vaccines, biologics, and animal health products. https://finance.eastmoney.com/a/202501073289649267.html
- Source: drugdu
- 176
- January 9, 2025
Poly Pharm Faces Potential Delisting After Two Years of Fabricated Financial Performance

On January 5, Poly Pharm announced that the company is under investigation by the China Securities Regulatory Commission (CSRC) for suspected violations of information disclosure laws and regulations. On January 4, the company received an “Advance Notice of Administrative Penalty” issued by the CSRC. According to the facts stated in the notice, the annual reports for 2021 and 2022 contain false records. Specifically, the fabricated operating revenue amounts to a total of 1.03 billion yuan, accounting for 31.08% of the total annual operating revenue disclosed for those two years. The total fabricated profit amounts to 695 million yuan, which constitutes 76.72% of the total annual profit disclosed for the same period. According to the facts established in the notice, Poly Pharm may engage in a significant violation that triggers mandatory delisting under the regulations of the “Shenzhen Stock Exchange’s Growth Enterprise Market Listing Rules (2024 revision),” which states that if ...
- Source: drugdu
- 348
- January 9, 2025
Sold for 4.5 billion! Why is another state-owned enterprise taking control of traditional Chinese medicine after selling medicine?

Accelerate the integration of state-owned assets and consolidate its leading position; Private traditional Chinese medicine enterprises are facing operational difficulties and are being rescued by state-owned assets; Industrial capital enters the market, promoting upstream and downstream collaboration. The triple logic, combined with policy effects, further promotes the inevitable trend of the integration of the traditional Chinese medicine industry to the waist and tail enterprises by 2025. In just two days since the beginning of 2025, two major events have already occurred: DLL3 has gone viral, and the new lung cancer star targets have attracted new trends; Shanghai Pharmaceuticals has locked in the exclusive large variety of traditional Chinese medicine, and plans to spend nearly 1 billion yuan to further integrate Hehuang Pharmaceuticals. With the state-owned “holding” of the traditional Chinese medicine industry, the value of once again has increased. On January 1st, Shanghai Pharmaceuticals announced its intention to jointly acquire ...
- Source: drugdu
- 339
- January 7, 2025
Did the new drug cost so much money and go to the wrong place?

The launch of new drugs seems to solve some clinical unmet problems, and theoretically, it seems to help improve the overall health of everyone. However, a recent paper published in The Lancet arrived at the opposite conclusion. They believe that over the past two decades, the funds used by the UK’s National Health Service (NHS) for newly approved drugs could actually bring more health benefits if they were instead invested in existing services. Investigation on NICE Database Researchers from the UK and the US first reviewed UK drug technology assessments published in the NICE (National Institute for Excellence in Healthcare Services) public database between 2000 and 2020. After investigating 183 drugs evaluated for 385 indications out of 339 evaluations in NICE’s new drug evaluation, they found that the median gain in quality adjusted life years (QALYs) was 0.49 throughout the entire evaluation, with moderate dispersion. Quality adjusted lifespan is an ...
- Source: drugdu
- 217
- January 7, 2025
Baide Medical’s stock surged 624%

On December 31, 2024 Eastern Time, Baird Medical Investment Holdings Ltd surged 623.81%. Baird Medical Investment Holdings Limited (hereinafter referred to as “Baird Medical”) is the substantive holding company of Baird (Suzhou) Medical Co., Ltd. Baide Medical officially went public on NASDAQ in the United States on October 2, 2024, through the backdoor acquisition of SPAC (Special Purpose Acquisition Company) ExcelFin Acquisition (XFIN). Baide Medical is a leading microwave ablation medical enterprise in China. According to the data, based on the sales revenue and sales of microwave ablation needles in 2022, Baide Medical ranks first among the suppliers of microwave ablation medical equipment for treating thyroid nodules and breast lumps in China. In addition, based on sales revenue in 2022, the company is the third largest supplier of microwave ablation medical devices in China. 01. After being listed for 3 months, the stock is like riding a roller coaster On ...
- Source: drugdu
- 262
- January 7, 2025
Developing Protein based Artificial Neural Networks

Cells naturally process various classification cues, such as stress and developmental signals, to initiate cellular functions and produce different outcomes; Immune cells respond to threats based on detected signals; The p53 signaling pathway determines whether to repair damage or initiate self destruction to prevent cancer. Scientists have been working hard to create artificial systems that can replicate this decision-making process within cells. Most existing attempts rely on DNA or RNA, which require further translation into proteins to perform their functions, resulting in a slow and less direct process. Recently, researchers from Westlake University and California Institute of Technology have not used DNA or RNA based systems, but have designed a fully protein based system in living cells, consisting of de novo designed protein heterodimers and engineered viral proteases to construct decision circuits that can process multiple signals and make decisions based on these signals. The research team named the system ...
- Source: drugdu
- 263
- January 7, 2025
Novartis accused of commercial bribery

New York (Reuters) – The U.S. Federal Court of Appeals for the Second Circuit has reinstated a lawsuit against Novartis. The lawsuit was filed by Steven Camburn, a former Novartis sales representative, alleging that Novartis illegally paid kickbacks to doctors to induce them to promote its multiple sclerosis drug Gilenya. Camburn said Novartis paid doctors thousands of dollars and set up business banquets in high-end restaurants to let them speak at events that were nominally academic conferences but were actually social activities to promote Gilenya. ▍Reported many times In 2013, the whistleblower sued Novartis under the U.S. False Claims Act, claiming that it paid $3,500 to doctor speakers at academic events to promote the sales of Gilenya. However, the lawsuit was dismissed, and the whistleblower filed lawsuits in other courts many times afterwards. But they all failed due to lack of sufficient specific evidence. But this time, the pharmacist’s complaint ...
- Source: drugdu
- 279
- January 7, 2025

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