PharmaFocus Today – Page 44 – media

Novo Nordisk applies for listing of growth hormone in China once a week

Original Medicine Guanlan Medicine Guanlan September 5, 2024 08:35 Shanghai Reported by WuXi AppTec Content Team Today (September 5th), the China National Medical Products Administration’s Center for Drug Evaluation (CDE) announced on its official website that Novo Nordisk’s application for the new drug market launch of Paxin Injection has been accepted. According to public information, this should be the weekly long-acting growth hormone Sogroya developed by Novo Nordisk ® (Somapacitan). The Phase 3 study of this product in China for the treatment of children with slow growth caused by insufficient secretion of growth hormone has been completed. Sogroya ® (somapactan) injection is a human growth hormone analog containing growth hormone similar to that produced by the human body, which can be used to treat adult growth hormone deficiency (AGHD). Sogroya ® has been approved in the United States, European Union, Japan, Australia, and Saudi Arabia for subcutaneous injection once ...
- Source: drugdu
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- September 7, 2024
Hengrui Pharmaceutical’s JAK1 inhibitor new indication application for market launch

Medical Guanlan Medical Guanlan September 5, 2024 08:35 Shanghai Reported by WuXi AppTec Content Team Today (September 5th), the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) just announced that Hengrui Pharmaceutical’s application for the new indication of imatinib sulfate tablets has been accepted, but the specific indication has not been disclosed yet. Ivarmacitinib tablet is an orally administered highly selective JAK1 inhibitor, which has previously submitted three marketing applications in China for the treatment of ankylosing spondylitis, atopic dermatitis, and rheumatoid arthritis. According to publicly available information from Hengrui Pharmaceutical, imatinib (SHR0302) is a independently developed JAK inhibitor that targets JAK1. It can specifically block the JAK/STAT pathway and reduce adverse reactions such as anemia and thrombotic diseases, while achieving good clinical efficacy. As an oral small molecule targeted drug, the convenient administration method can significantly improve patients’ treatment ...
- Source: drugdu
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- September 7, 2024
Hainan Free Trade Harbor Drugs, Medical Equipment to Enjoy “zero Tariffs”

People’s Daily, Beijing, September 6 (Reporter Wang Zhen) According to the General Administration of Taxation website, September 5, the Ministry of Finance, the National Health Commission, the General Administration of Customs, the General Administration of Taxation, the State Administration of Pharmaceutical Administration and other five departments issued a notice on the Hainan Free Trade Port drugs, medical equipment “zero tariff” policy. The notice makes it clear that before the closure of the entire island operation, in Boao Lesheng International Medical Tourism Pioneer Zone in Hainan, registered with an independent legal personality and recognized medical institutions, medical education institutions of higher learning, pharmaceutical research institutes, the import of medicines and medical devices under the provisions of this notice, and in accordance with the provisions of the use of import tariffs can be exempted from import tariffs, import link value-added tax. The introduction of “zero tariff” policy for drugs and medical devices ...
- Source: drugdu
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- September 7, 2024
Hengrui Medicine’s “JAK1 inhibitor” application for alopecia areata indication has been accepted

Recently, the drug marketing authorization application for the JAK1 inhibitor amaxitinib sulfate tablets (SHR0302 tablets) was accepted by the State Food and Drug Administration. This product is suitable for adult patients with severe alopecia areata. At present, no JAK1 inhibitor self-developed by domestic companies has been approved for marketing. In addition to the indications for alopecia areata, the marketing authorization application for Amaxitinib Sulfate Tablets has been accepted by the State Food and Drug Administration for three indications, namely: moderate to severe atopic dermatitis in adults and adolescents aged 12 years and above, and ankylosing spine. inflammation and moderate to severe active rheumatoid arthritis. In June 2024, the main research endpoint of the Phase III clinical trial of Emmaxitinib Sulfate Tablets reached the superiority standard preset in the protocol. This study is a randomized, double-blind, and placebo-controlled Phase III study to evaluate the effectiveness and safety of amaxitinib sulfate tablets ...
- Source: drugdu
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- September 7, 2024
The Chinese medicine industry has entered the digital stage

The research and development of new Chinese medicines is a manifestation of innovation in the field of Chinese medicine. The country has issued a number of policies to support the research and development of new Chinese medicines. However, the launch of new drugs requires clear pharmacological effects and standardized clinical verification, which are different from the traditional empirical verification of Chinese medicine. Enterprises need to clarify the composition of new Chinese medicines and conduct targeted pharmacological experiments. At present, the research and development of new Chinese medicines is challenging, but the application of digital technology can solve these problems. At the same time, through data sharing, it also improves the efficiency and success rate of research and development of new Chinese medicines. In the eleventh point of the “Opinions”, it is also specifically mentioned to promote the application of scientific data in Chinese medicine. Strengthen the retrieval and utilization of ...
- Source: drugdu
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- September 7, 2024
In 2024, consumer healthcare will have a hard time

According to statistics from Guangdong Securities, the domestic consumer healthcare market size corresponds to a trillion-level market. Among them, the market size of specialized medical fields such as ophthalmology, stomatology, and assisted reproduction can reach 382.62 billion yuan, and is expected to reach 605.88 billion yuan in 2025; the market size of the medical beauty field has reached 226.7 billion yuan, and is expected to reach 352.9 billion yuan in 2025. In such a vast market, growth should be the first priority. However, after the epidemic, the expected consumption recovery and rebound have not arrived. Since the third quarter of last year, the overall economic environment has continued to weaken, and the operating pressure of sub-industries such as medical services, consumer equipment, and medical beauty with consumer attributes has increased, and most of them have not met expectations. This was particularly evident in the second quarter of this year, and ...
- Source: drugdu
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- September 7, 2024
635 million US dollars! Anmai Biological BCMA × CD3 Double Antibody Successfully Goes to Sea

On September 4th, Anmai Biotechnology announced that it has reached a licensing agreement with Vignette Bio for the T cell conjugation (TCE) molecule EMB-06 targeting BCMA. picture According to the agreement, Amway Bio will grant Vignette the exclusive right to develop and commercialize EMB-06 outside the Greater China region (including Chinese Mainland, Hong Kong, Macao and Taiwan), and Amway Bio will reserve the right of EMB-06 in the Greater China region. Anmai Biotechnology will receive a total down payment of $60 million in cash and Vignette equity, and will have the right to receive up to $575 million in milestone payments for development, listing, and commercialization, as well as revenue sharing based on net sales. EMB-06 is the first TCE molecule developed under the T cell conjugation platform of Anmai Biotechnology, which combines Anmai Biotechnology’s self-developed FIT Ig bispecific antibody platform and CD3 binding domain library, as well as Anmai ...
- Source: drugdu
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- September 6, 2024
Mindray Medical Ranks as one of the Best Brand in China

On September 3rd, Interbrand, a global brand strategy management consulting and design company, released the “2024 China’s Best Brands Ranking”. Mindray Medical was selected and maintained a strong upward trend for the second consecutive year, ranking 34th on the list with a brand value of 11.541 billion yuan, an increase of 18% compared to last year. Under the dual tests of economic cycles and market competition, the total value of the brands listed in the “2024 China’s Best Brands Ranking” maintained a slight increase, reaching 3371.26 billion yuan, showing an overall stable trend. Among them, over 60% of brands have achieved value growth, demonstrating strong brand resilience and innovation drive, including Mindray Medical. It should be emphasized that Mindray Medical is also the top ranked medical device brand on this list. So, what exactly did Mindray Medical rely on to achieve this result? In the process of promoting the upward ...
- Source: drugdu
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- September 6, 2024
Two innovative medical devices have been approved for market launch

On September 3rd, the National Medical Products Administration announced that it has recently approved the registration applications for two innovative products, the “Navigation Positioning Microwave Ablation System” of True Health (Zhuhai) Medical Technology Co., Ltd. (hereinafter referred to as “True Health Medical”) and the “Hepatitis B Virus Surface Antigen (HBsAg) Detection Kit (Chemiluminescence Method)” of Fuji Ruibiou Co., Ltd. (hereinafter referred to as “Fuji Ruibiou”). True Health Medical: International First Product Founded in 2018, True Health Medical is a national high-tech enterprise specializing in the research and production services of surgical robots. Based on artificial intelligence technology, it integrates intelligent robot systems into the diagnosis and treatment process through the close integration of industry, academia, research, and medicine, achieving a comprehensive medical technology system with precise puncture of soft tissue lesions throughout the body as a diagnostic and treatment method. Precise puncture is a means to deliver minimally invasive treatment ...
- Source: drugdu
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- September 6, 2024
Zhifei Biological’s 23-valent Pneumococcal Vaccine Price Reduction of Nearly 30%, Another Vaccine Field Will Be Involved in the “Price War”?

September 3, Jilin Province Public Resources Trading Center issued a document that will Zhifei Biological 23-valent pneumococcal polysaccharide vaccine from the original 298/branch down to 209 yuan/branch, down 29.87%. The following day, the Jiangsu Provincial Public Resources Trading Center issued a notice that also reduced the vaccine from 298/branch to 209 yuan/branch. At the end of August last year, Zhifei Biological’s 23-valent pneumococcal polysaccharide vaccine was formally approved for marketing in China for the prevention of infectious diseases caused by pneumococcus bacteria in children aged 2 years and above and adults. According to the half-year report of Zhifei Biological 2024, the approved and issued volume of its 23-valent pneumonia vaccine was 160,000 doses from January to June this year. During the same period, the approved and issued volume of Merck Sharp & Dohme’s 23-valent pneumonia vaccine, for which Zhifei Bio is the agent, amounted to 845,000 units, a year-on-year increase ...
- Source: drugdu
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- September 6, 2024

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