On May 21, Mengke Pharmaceuticals (688373) announced that the company’s new drug marketing authorization application for contezolidinone sodium for injection was accepted by the National Medical Products Administration. The drug is a Class 1 antibacterial drug of the oxazolidinone class independently developed by the company. The previous contezolidinone tablets were approved in 2021 for the treatment of complicated skin and soft tissue infections. The sodium contezolizumab for injection applied for this time is a water-soluble prodrug of contezolizumab. Based on the background that the prodrug has been approved, the company has carried out relevant Phase III clinical trials and successfully achieved the primary efficacy endpoint. Although the new drug marketing authorization application has been accepted, the announcement mentioned that the application still needs to go through review, clinical trial site inspection and approval, and the time and results are uncertain, so it will not have a significant impact on the ...
On May 20, 3SBio announced that it had signed an exclusive licensing agreement with Pfizer, granting Pfizer the exclusive rights to develop, produce, and commercialize its independently developed breakthrough PD-1/VEGF bispecific antibody SSGJ-707 worldwide (excluding mainland China). At the same time, it retained the relevant rights of the product in mainland China and granted Pfizer the option to commercialize the product in mainland China. The total amount of this cooperation is as high as US$6.05 billion, including an upfront payment of US$1.25 billion and development, regulatory approval and sales milestone payments of up to US$4.8 billion. In addition, Pfizer will subscribe to 3SBio’s common stock worth US$100 million. SSGJ-707 is a bispecific antibody targeting PD-1/VEGF independently developed by 3SBio based on its proprietary #CLF2 platform. In the Phase II clinical phase analysis, it demonstrated excellent objective response rate (ORR) and disease control rate (DCR) in the treatment of patients with ...
520, as the Internet Valentine’s Day, is deeply loved by couples. It has now become a popular day for pharmaceutical companies to officially announce cooperation. Today, a blockbuster news swept the entire pharmaceutical industry: Pfizer invested a huge amount of US$6.05 billion to introduce 3SBio’s PD-1/VEGF bispecific antibody SSGJ-707, marking another significant new milestone in China’s innovative drug overseas expansion – becoming the domestic license deal project with the highest down payment to date. However, amid this wave of attention, there is another innovative drug overseas collaboration that cannot be ignored today. That is the major collaboration between Jingyin Pharmaceutical and CRISPR Therapeutics. The two parties will work together to promote the development of innovative siRNA therapies, and the amount of this collaboration is as high as US$895 million (approximately RMB 6.5 billion). 6.5 billion yuan cooperation On May 20, Jingyin Pharmaceutical announced a strategic partnership with CRISPR Therapeutics, focusing ...
Drugdu.com expert’s response: Compliance review is an essential task undertaken by enterprises or organizations to ensure that their business activities adhere to legal and regulatory requirements, industry norms, and internal rules and regulations. The standards and procedures for compliance review vary depending on factors such as industry, region, and enterprise size, but they typically encompass the following core elements: I. Standards for Compliance Review Legal and Regulatory Requirements Applicable Laws: These include national laws, administrative regulations, and local regulations, such as the Company Law, Labor Contract Law, and Environmental Protection Law. Industry Regulations: These are specific regulatory requirements for particular industries, such as anti-money laundering regulations in the financial sector and privacy protection laws in the medical industry. International Treaties or Agreements: When engaging in cross-border business, enterprises must comply with international conventions or bilateral agreements (e.g., GDPR requirements for cross-border data flows). Internal Rules and Regulations of the Enterprise ...
On May 20, Changshan Pharmaceutical(300255) announced that the company’s drug Nadroparin Calcium Injection has obtained the drug registration certificate issued by the Belarusian drug administration department. Nadroparin calcium injection is an injection with specifications of 0.4ml and 0.6ml. This drug is mainly used to treat moderate or high-risk venous thrombosis, prevent venous thromboembolic diseases, treat established deep vein thrombosis, and be used in combination with aspirin to treat unstable angina and acute stage of non-Q wave myocardial infarction; and prevent blood clot formation in extracorporeal circulation during hemodialysis. In the first quarter of 2025, Changshan Pharmaceutical achieved revenue of 259 million yuan and net profit attributable to shareholders of the parent company of 3.78 million yuan. https://finance.eastmoney.com/a/202505203409519560.html
Beihai Kangcheng announced that its independently developed injectable velaglucerase beta (Gorinin, CAN103) has been approved for marketing by the China National Medical Products Administration on May 15, 2025 for the treatment of type I and type III Gaucher disease. Gaucher disease is an autosomal recessive genetic disease caused by a deficiency of glucocerebrosidase, which leads to the accumulation of glucocerebroside in the body and causes a variety of symptoms. Gorenin is the first independently developed long-term enzyme replacement therapy in China suitable for adolescents aged 12 years and above and adults with type I and type III Gaucher disease. https://finance.eastmoney.com/a/202505203409423342.html
Recently, Duke Herrell, CEO of Virtuoso Surgical, announced that the robotic endoscope system developed by the company has successfully completed the first batch of human clinical trials. This milestone event marks an important technological innovation in the field of minimally invasive surgery. It is reported that from May 12 to 13, the VIABLE clinical trial was performed by Professor Yuanjin Zhang of the Chinese University of Hong Kong, who successfully performed en bloc resection of bladder lesions on 6 patients, treating a total of 11 lesions. Professor Yuanjin Zhang is not only a top surgical expert in the field of bladder cancer, but also the pioneer of the “en-bloc” technique, which can significantly improve the completeness and accuracy of tumor resection. According to Virtuoso, the system is equipped with two needle-shaped robotic arms that pass through a sheath with a diameter of less than 1 cm and perform surgical operations ...
Recently, the Montana legislature passed a bill that allows medical institutions to sell drugs that have only passed Phase I clinical trials without the need for U.S. FDA approval. The legislation was promoted by a group of people committed to extending human life span, including scientists, libertarians and opinion leaders. They hope that Montana can become a testing ground for medical innovation, providing more options for patients, especially those with terminal illnesses or those who are ineffective with existing treatments, so that they can have earlier access to some experimental drugs that may have potential therapeutic effects. What exactly does this bill include? First, doctors can apply for a license to open an experimental treatment clinic to recommend and sell non-FDA-approved therapies to patients. #No FDA approval required At the same time, these clinics must disclose all treatment effect and adverse event data to patients and regulators, and publish treatment ...
Intestinal microbes that survive chemo can rid the gut of excess chemo drugs and produce a vitamin that helps to stem nausea. Chemotherapy doesn’t just kill cancer cells. It also affects the microbes in the digestive tract. Researchers at UC San Francisco have discovered that some gut bacteria can reduce the side effects of these potent treatments, and that one family of cancer drugs may actually boost these protective bacteria. The phenomenon could help physicians to predict the severity of a patient’s side effects and points the way to supplements that could help those whose guts aren’t sufficiently protecting them. Clearing drugs from the body Turnbaugh’s team found that colorectal cancer patients taking a class of chemotherapy drugs known as fluoropyrimidines had much less diverse microbiomes in their digestive systems. But the surviving bacteria did something amazing. “They were able to gobble up the chemotherapy and chemically transform it ...
|In a major policy shift, federal health officials anticipate the shots will be made available to adults 65 and older as well as children and younger adults who have one or more risk factors that make them more vulnerable to severe COVID-19. The Trump administration on Tuesday unveiled a new plan for updated COVID-19 shots that will likely significantly limit the number of Americans who have access to the vaccines in the fall. Federal health officials anticipate the shots will be available to adults 65 and older as well as children and younger adults who have one or more risk factors – like cancer, lung disease or obesity as measured by body mass index – that make them more vulnerable to severe COVID-19. For other Americans, the Food and Drug Administration will require an additional clinical trial before signing off on their shots. FDA Commissioner Marty Makary and FDA vaccine ...
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