PharmaFocus Today – Page 53 – media

Clinical study of innovative gene therapy drug LY-M003 injection launched

LY-M003 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. Recently, a prospective, single center, open label, single arm, single dose clinical study evaluating the safety, tolerability, and efficacy of LY-M003 injection in the treatment of adult patients with Wilson’s disease was launched at the First Affiliated Hospital of Zhejiang University School of Medicine (hereinafter referred to as “Zhejiang First Hospital”). The project was led by Professor Yu Chaohui, the leader of the Gastroenterology Department, as the main researcher. LY-M003 injection is an innovative gene therapy drug developed by Lingyi (Hangzhou) Biotechnology Co., Ltd. (hereinafter referred to as “Lingyi Biotechnology”). The Department of Gastroenterology at Zhejiang First Hospital ...
- Source: drugdu
- 107
- September 19, 2024
1.5 billion US dollars! Capricor Therapeutics partners with Nippon Pharmaceutical Co., Ltd

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. On September 17, 2024, Capricor Therapeutics, a biotechnology company developing transformed cell and exosome therapies for the treatment of rare diseases, announced that it had signed a binding term sheet with Nippon Pharma. The terms state that Nippon Pharma will commercialize and distribute Capricor’s main asset, deramiocel, in Europe for the treatment of Duchenne muscular dystrophy (DMD). Capricor will receive a $15 million equity investment at a 20% premium and a $20 million advance payment upon signing the final agreement. The potential milestone amount is as high as $715 million, with product revenue accounting for double digits. The total ...
- Source: drugdu
- 91
- September 19, 2024
Chinese non-opioid long-acting analgesics “break through one after another”

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 ...
- Source: drugdu
- 88
- September 19, 2024
National Drug Administration Advances the Development of Online Sales Monitoring Platform for Pharmaceuticals and Cosmetics

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 ...
- Source: drugdu
- 76
- September 19, 2024
The tenth batch of national procurement is on the way

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 ...
- Source: drugdu
- 75
- September 19, 2024
The development of the new OTC market failed miserably! 5 points of retrospective thinking

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 ...
- Source: drugdu
- 68
- September 19, 2024
Johnson & Johnson’s IL-23 Dual Inhibitor Guselkumab Approved by FDA for Ulcerative Colitis

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 ...
- Source: drugdu
- 75
- September 18, 2024
What’s Next?

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 ...
- Source: drugdu
- 80
- September 18, 2024
Leading the development of antibody drugs! Zhengda Tianqing Nanjing Shunxin Pharmaceutical was recognized as “Nanjing Engineering Research Center”

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 ...
- Source: drugdu
- 156
- September 18, 2024
From minerals to tablets

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. ...
- Source: drugdu
- 89
- September 18, 2024

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