Recently, Kelun Pharmaceutical announced that its subsidiary Hunan Kelun Pharmaceutical’s chemical drug “Bupivacaine Liposome Injection” was approved for marketing by the National Medical Products Administration (trade name Bruco®), which was approved according to Class 3 chemical drugs and deemed to have passed the generic drug quality and efficacy consistency evaluation. Kelun Pharmaceutical’s Bruco® is the second bupivacaine liposome injection product to be launched in China. Hengrui Medicine’s bupivacaine liposome injection generic drug (trade name: Aihengping) was approved in November 2022. It is the world’s first generic drug and also the first long-acting postoperative analgesic drug to be launched in China. In July this year, Aihengping was approved for marketing by the FDA, becoming the world’s first manufacturer to obtain generic drug approval for this variety in the United States. Behind the successful breakthroughs of domestic pharmaceutical companies is the growing market demand in the field of long-acting postoperative analgesic preparations ...
Vice Minister Huang Guo of the National Drug Administration recently revealed that the agency is leading the modernization of drug regulation through information technology. The administration continues to implement the Smart Drug Regulation Action Plan, focusing on building an integrated system for the registration and approval of drugs, medical devices, and cosmetics. This initiative aims to fulfill the “efficient handling of single transactions” requirement, achieving seamless cooperation throughout the entire process from acceptance and review to approval and certification. As a result, the volume of online acceptance and the rate of timely conclusions have steadily increased, significantly enhancing the quality and efficiency of reviews and approvals. Currently, all government service matters handled by the National Drug Administration have been transitioned to 100% online processing, and all enterprise-related certificates at the bureau level have been fully digitized. The total number of electronic certificates issued has exceeded 170,000, allowing enterprises to access ...
With the tenth batch of national procurement about to start, we are once again standing at a new starting point in history, ready to welcome this new wave of reforms in the pharmaceutical industry. On January 9, 2024, the National Medical Security Work Conference was held in Beijing. It was mentioned that the centralized procurement should be promoted to “expand and improve quality”. A new batch of national organized centralized procurement of drugs and consumables will be carried out, and the selected varieties in the centralized procurement will be continued after the expiration of the agreement, so that the total number of national and provincial centralized procurement drugs will reach at least 500, an increase of 50 compared with 2023. In May, the National Medical Insurance Administration issued the “Notice on Strengthening Regional Coordination to Improve the Quality and Expand the Scope of Centralized Procurement of Medicines in 2024”, which ...
The announcement of the complete closure of Shenzhen Zhonglian Pharmacy also announced that this once top 100 chain in the country could not withstand the economic downturn and collapsed. It also brought back the author’s memories of developing a new OTC market in Shenzhen many years ago. Shenzhen, the forefront of China’s reform and opening up, the first special economic zone, is not only the “holy land” in the hearts of countless businessmen, but also the place where miracles are born. In August 2001, I was sent to Shenzhen by the company to develop the market due to my outstanding performance at the age of 25. At that time, the company where the author worked was mainly engaged in women’s products (sanitary napkins, panty liners), and its business scope was mainly in the southwest region. Based on the concept of increasing the added value of women’s care products, it developed ...
On September 11, 2024, Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for the treatment of moderate to severe active ulcerative colitis (UC) in adult patients. The company claims that Tremfya is the first and only dual-action inhibitor targeting interleukin 23 (IL-23) approved for the treatment of active ulcerative colitis, further solidifying Johnson & Johnson’s leadership in the field of inflammatory bowel disease. Guselkumab is the first approved interleukin 23 (IL-23) inhibitor in the world, selectively binding to the p19 subunit of IL-23 to inhibit its interaction with the IL-23 receptor. It has shown strong efficacy for various autoimmune diseases; it can block IL-23 while also binding to the CD64 receptors on cells that produce IL-23. It is currently approved for the treatment of plaque psoriasis, active psoriatic arthritis, and UC. Furthermore, in June 2024, Johnson & Johnson submitted a supplemental Biologics ...
Over the past decade, the cross-border medical intermediary industry has experienced a boom, followed by a sharp decline during the pandemic. It has only been after the pandemic that the industry began to recover, but very few companies have managed to endure to this point. Recently, the company Shengnuo Yijia announced a partnership with the Hong Kong Yanghe Medical Group, launching a patient service center in the Yanghe facility to assist critically ill patients from mainland China in seeking medical treatment in Hong Kong. Previously, Shengnuo Yijia focused on bringing patients to the U.S., U.K., Japan, and other overseas regions for treatment. Now, they are increasing efforts to explore the Hong Kong medical market. How should we view this change? According to Shengnuo Yijia Chairman Cai Qiang, cross-border medical services have entered their next phase. The key question remains: Where are the new opportunities in this industry? Seeking Treatment in ...
The “Nanjing Antibody Drug Screening and Transformation Engineering Research Center” built this time aims at the difficulties and pain points of key technologies and results transformation in the process of antibody drug research and development and industrialization. It will build and improve the two key platforms of “core technology breakthrough” and “innovation results transformation” to conduct independent localization research on materials and consumables required for the production of biological products, including cell culture medium, protein chromatography medium and virus removal nanofiltration membrane, and carry out results transformation and industrialization development for key innovative antibodies, antibody-drug conjugates and recombinant humanized proteins. Next, the “Nanjing Antibody Drug Screening and Transformation Engineering Research Center” will further promote the development of biological products and the joint development of upstream and downstream industrial chains, complete the transformation from biosimilars to innovative biological products, develop new antibody drugs with independent intellectual property rights, and ensure the ...
F Lab is suitable for a wide range of applications, such as feasibility studies, quality control, and troubleshooting during production. The powder analyzer can be used to check the tableting process of a formulation. Users can test raw materials under special conditions and compare various formulations. The compact device can even detect changes in the mineral mixture due to compositional changes. This powder analyzer is therefore a great support for the development of new products. The powder analyzer can be automated and is available in two models: the F Lab 5 with a pressing force of 5 kN for tablets up to 10 mm in diameter, and the F Lab 10 with a pressing force of up to 10 kN for tablets up to 15 mm in diameter. Depending on the customer’s needs, the device can be combined with an automatic data evaluation and display program and other analysis equipment. ...
On September 13th, as the autumn atmosphere grew stronger, the establishment ceremony of Heyuan Hemei Regenerative Medicine Center was successfully held at 3888 Canghai Road and Heyuan Intelligent Manufacturing Precision Medical Industry Base in Lingang New Area, Shanghai. At the event, all the guests gathered together to witness this milestone moment.The successful holding of the establishment ceremony of Heyuan and Hemei marks a further expansion of Heyuan Group’s business map and a solid step forward in the strategic layout of cell therapy. As a high-tech enterprise deeply involved in the fields of cell and gene therapy, Heyuan Group relies on its own nearly 5000 square meters of comprehensive research and development production platform, as well as nearly 80000 square meters of port base, to continuously accelerate the research and commercialization process of cell and gene therapy. The establishment of Heyuan Hemei Regenerative Medicine Center will help enterprises build a more ...
Disclaimer: Due to limited proficiency, errors are inevitable, or some information may not be timely. Please feel free to leave a message to indicate. This article only provides an introduction to medical and health-related drugs, and does not recommend treatment plans (if applicable); This article does not constitute any investment advice. Lilly said that the company had completed the $800 million Kinsale factory expansion project to increase the production of its obesity and diabetes drugs Mounjaro and Zepbound. At the same time, the pharmaceutical company will also invest $1 billion to build a factory in Limerick to increase the production of biopharmaceutical raw materials, especially Kisunla, a drug approved by the FDA to treat Alzheimer’s disease two months ago. The production of active pharmaceutical ingredients is expected to begin in 2026. Lilly stated that Limerick’s expansion will add tools for artificial intelligence, automated robots, and machine learning to the website. ...
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