PharmaFocus Today – Page 146 – media

Two innovative medical devices have been approved for market launch

Recently, the National Medical Products Administration approved the registration applications for two innovative products, the “Proton Therapy System” of Maisheng Medical System Company (hereinafter referred to as Maisheng Medical) and the “Cardiac Pulse Electric Field Ablation Device” of Shanghai Hongtong Industrial Co., Ltd. (hereinafter referred to as Shanghai Hongtong). Maisheng Medical, the first product to be launched in China Maisheng Medical was founded in 2004 and is headquartered in Littleton, Greater Boston, Massachusetts, USA. We specialize in the research, development, production, installation, and service of miniaturized proton therapy equipment for cancer treatment, with branch structures in Europe and Asia. We are a leader in the field of miniaturized proton therapy. The miniaturized proton radiotherapy system developed based on its own core technology has unique advantages such as good clinical efficacy, high integration level, small footprint, and low overall customer ownership cost. At present, Maisheng Medical has advanced proprietary intellectual property ...
- Source: drugdu
- 350
- December 19, 2024
5 innovative medical devices enter special review process

On December 16th, the National Medical Products Administration’s Device Review Center released the results of the special review application for innovative medical devices (No. 11 of 2024), intending to approve 5 innovative medical device projects to enter the special review process. 1. Hot steam ablation system: Shanghai Lixiao Medical Technology Co., Ltd Lixiao Medical was founded in January 2019 by Dr. Cheng Lifei, Global Vice President of Business Development at Medtronic. It is an innovative medical technology platform that focuses on the introduction of advanced medical technologies from overseas, local research and development, and industrialization. It specializes in the research and development of medical devices for the treatment of chronic diseases such as cardiovascular, urinary, and respiratory diseases. As of now, Lixiao Medical has completed two rounds of financing of nearly one billion US dollars, led by well-known investment institutions such as Eli Lilly Asia, Sequoia Capital, and WuXi AppTec. ...
- Source: drugdu
- 392
- December 19, 2024
The two weight loss giants were launched on the same day on Meituan. Has the new battle begun?

The battle between the two weight loss giants has officially entered the deep water period. From clinical PK to production capacity competition, to the future layout competition, Novo Nordisk and Eli Lilly are fighting fiercely. With the advancement of the commercialization of the two giants in China, the new battle has surfaced. On December 9, the oral version of semaglutide was launched on Meituan’s entire network, and at the same time, the reservation service for telpotide was also opened. The first confrontation between the two parties in the Chinese market has once again attracted widespread attention from the market. This indicates that we can no longer use the perspective of traditional medicine to view GLP-1R drugs that are increasingly closely integrated with consumer medicine. That is, traditional channels such as pharmacies are certainly very critical, but online channels are also becoming more and more indispensable. Otherwise, Eli Lilly would not ...
- Source: drugdu
- 398
- December 19, 2024
long-acting AIDS prevention drugs rank first

On December 12, 2024, the top ten scientific breakthroughs of the year in Science magazine arrived as expected. An AIDS drug, Lenacapavir, was named the top scientific breakthrough of the year. The drug only needs to be injected once every 6 months and has achieved remarkable success in preventing HIV infection, which is expected to help end the HIV/AIDS epidemic. The interim analysis data of the key Phase 3 clinical trial released by Gilead Sciences showed that twice-yearly dosing achieved 100% AIDS prevention effect in women. On June 20, 2024, Gilead Sciences announced the interim analysis results of its key Phase 3 clinical trial of Lenacapavir, an AIDS prevention drug, showing that only twice-yearly dosing achieved 100% AIDS prevention effect in women. It is reported that this project is the most comprehensive and diverse AIDS prevention trial project ever conducted. Dr. Merdad Parsey, Gilead’s Chief Medical Officer, said that two ...
- Source: drugdu
- 628
- December 19, 2024
From PROTAC to RIPTAC, it is a challenge and an opportunity

In 2001, Craig Crews, the former founder of Arvinas and Professor of Yale University, first proposed the concept of PROTAC, leading a new revolution in small molecule innovative drugs. In 2023, Professor Crews founded HALDA Therapeutics and unveiled their latest technology platform RIPTAC at the ASCO-GU conference. At the same time, he published the latest article on bioRxiv, describing the results of the RIPTAC proof-of-concept study. In 2024, HALDA Therapeutics announced the completion of a $126 million Series B financing, and emphasized that the funds raised will be used for clinical trials of two candidate drugs in patients with prostate cancer and breast cancer. From PROTAC to RIPTAC, it was originally an innovative theory proposed by the same professor, but it is essentially based on two different directions. The former emphasizes the transition from “placeholder-driven” to “event-driven”, while the latter returns from “event-driven” to “placeholder-driven”. What is the reason? More ...
- Source: drugdu
- 906
- December 19, 2024
Mabwell Biotechnology Plans to Issue H Shares

December 15 Mabwell Biotechnology (688062) announced a preliminary announcement regarding its plan to issue H shares and list on the Hong Kong Stock Exchange. The announcement stated that in order to meet the funding needs for the company’s operational development, achieve sustainable growth, and enhance its level of internationalization, the company intends to issue H shares abroad and list on the main board of the Hong Kong Stock Exchange. The company will choose an appropriate time and issuance window to complete this task within the validity period of the shareholders’ meeting resolution. As of now, the company is actively discussing relevant matters concerning the H share issuance with related intermediary institutions, but specific details have not yet been finalized. The announcement emphasized that the review and approval process for the issuance and listing of H shares involves significant uncertainties, and investors should remain vigilant about this situation. In the first ...
- Source: drugdu
- 378
- December 19, 2024
Siemens Healthineers partners with Paris Public Assistance Hospital (AP-HP)

Recently, the largest university hospital system in Europe, Paris Public Assistance Hospital (AP-HP), reached a comprehensive framework agreement with Siemens Healthineers, marking the first such cooperation between the two parties. It is reported that this collaboration aims to address France’s major healthcare challenges by jointly developing innovative solutions for chronic diseases, neurological and cardiovascular diseases, musculoskeletal disorders, and cancer. 01. Joining hands with the largest university hospital system in Europe The agreement was signed by Nicolas Revel, CEO of Paris Public Aid Hospital, Bernd Montag, CEO of Siemens Healthineers, and Hassan Safer Tebbi, Regional Head of Siemens Healthineers France, Belgium, and Luxembourg. It is understood that this is the first time that Paris Public Aid Hospital has carried out such a large-scale cooperation with an imaging company. This collaboration not only involves clinical research, but also encompasses systematic changes in healthcare service provision, utilizing advanced technology to adapt to the ...
- Source: drugdu
- 324
- December 18, 2024
After investing in healthcare, giants may lay off 15000 employees

According to the well-known anonymous workplace community Teamblind, Microsoft plans to lay off 10000 to 15000 employees in January 2025. Once this news was released, it immediately attracted widespread attention from all sectors of society. If the layoff plan is confirmed, it will not only have a significant impact on Microsoft itself, but also affect the entire technology industry. According to insiders, Microsoft’s compensation plan for this round of layoffs may follow the old practice of the “N+2” model. At present, the specific departments involved in the layoff plan and whether it covers the China region are not yet clear. This has increased speculation from the outside world about Microsoft’s future strategic adjustments. Layoffs are usually related to a company’s business restructuring, cost reduction, or strategic transformation, and Microsoft’s move may indicate significant adjustments in certain business areas. It is worth noting that as a tech giant with years of ...
- Source: drugdu
- 308
- December 18, 2024
The application documents for the merger and reorganization of New Novartis have been accepted, accelerating the layout of the innovative drug track

After nearly a year of planning, there have been new developments in the restructuring of New Novartis. Xinnuowei recently announced that the company has received a notice from the Shenzhen Stock Exchange regarding the acceptance of the application documents for the issuance of shares to purchase assets and raise supporting funds by Shiyao Innovation Pharmaceutical Co., Ltd. The Shenzhen Stock Exchange has verified the application documents submitted by the company for the issuance of shares to purchase assets and raise supporting funds, and considers them complete. Therefore, the company has decided to accept them. However, behind this restructuring plan, both New Novartis and its target company, Shiyao Group Baike (Shandong) Biopharmaceutical Co., Ltd. (hereinafter referred to as “Shiyao Baike”), are facing significant performance challenges that cannot be ignored. In the first three quarters of 2024, New Norwe experienced a double decline in revenue and net profit, with a year-on-year decrease ...
- Source: drugdu
- 295
- December 18, 2024
Xinda Biotech and Lilly have reached a cooperation agreement; Yuanda Pharmaceutical’s innovative ophthalmic drug NDA application accepted | Medical Early Reference

NO.1 Xinda Biotech and Eli Lilly reach commercial cooperation on third-generation BTK inhibitors On December 16th, Xinda Biotechnology and Eli Lilly and Company Limited jointly announced the following cooperation agreement regarding the rights and interests of Eli Lilly and Company Limited’s non covalent (reversible) BTK inhibitor “Jepanib” (100mg and 50mg tablets of Pitobutinib): Xinda Biotechnology will be responsible for the import, sales, promotion, and distribution of “Jepanib”, while Eli Lilly and Company Limited will be responsible for the research and development of “Jepanib” and post marketing medical affairs. This drug is the latest generation, the world’s first and only approved non covalent (reversible) BTK inhibitor. Comment: Eli Lilly and Company is a long-term partner of Xinda Biotechnology. In the past 10 years, the two parties have reached 5 cooperation agreements. The promotion of this cooperation can not only enable Xinda Biotechnology to obtain cash flow and enrich its own pipeline, ...
- Source: drugdu
- 399
- December 18, 2024

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