Search Results for “research” – Page 53 – media

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

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 a week as a replacement therapy for endogenous growth hormone in adult growth hormone deficiency (AGHD) patients. ...
- Source: drugdu
- 113
- September 7, 2024
Domestic neural device giant sprints for IPO

Recently, Beijing Pinchi Medical Equipment Co., Ltd. (hereinafter referred to as “Pinchi Medical”) completed its IPO counseling and registration with the Beijing Securities Regulatory Bureau, with the counseling agency being China International Capital Corporation (CICC). According to the coaching work arrangement, CICC plans to complete the coaching plan for Pinchi Medical in November December this year and apply for coaching acceptance from the Beijing Securities Regulatory Bureau. After completing the coaching acceptance, Pinchi Medical may apply for IPO. This is another brain pacemaker company planning to go public in 2023, following Jingyu Medical’s IPO guidance filing. According to reports from Smart Medical Devices, the only two local companies that mass produce brain pacemakers have now embarked on the path of IPO and planned to go public. Tsinghua endorsement, Pinchi Medical is aiming for IPO Pinchi Medical was founded in 2008 and is a high-tech enterprise specializing in the research, development, ...
- Source: drugdu
- 74
- September 7, 2024
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
- 73
- 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
- 74
- 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
- 63
- 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
- 58
- September 7, 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
- 90
- 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
- 82
- September 6, 2024
AstraZeneca China’s structure will be adjusted

According to various sources in the industry, AstraZeneca China’s biopharmaceutical business BBU and omnichannel business unit structure will undergo a series of adjustments on October 1 this year. AstraZeneca China’s biopharmaceutical business and omnichannel business unit will be officially merged to form a new AstraZeneca China biopharmaceutical business (BBU). Merge the respiratory inhalation business unit, respiratory atomization business unit and digestive business unit to form the respiratory digestive business unit; merge the biologics business unit, vaccines and immunotherapy, and autoimmune business unit; merge the biologics business unit, vaccines and immunotherapy, and autoimmune business unit to form the respiratory and autoimmune biopharmaceuticals, vaccines and immunotherapy business units. According to incomplete statistics, this is at least the third adjustment of AstraZeneca China this year. “Adjustment” seems to be the key to AstraZeneca China’s performance development. AstraZeneca once said that the new map will add momentum to the long-term development of its business. ...
- Source: drugdu
- 77
- September 6, 2024
As a new upstart in the imaging industry, is its billion-dollar halo no longer there?

Recently, United Imaging Healthcare released its 2024 semi-annual report. In the first half of the year, United Imaging Healthcare’s revenue was 5.333 billion yuan, a year-on-year increase of 1.18%; it achieved a net profit attributable to the parent of 950 million yuan, a year-on-year increase of 1.33%; and a net profit attributable to the parent of 798 million yuan, a year-on-year increase of 1.39%. In the semi-annual report, the growth of United Imaging Healthcare slowed down, and based on this, the stock price has been falling. Now that the market value of United Imaging Healthcare is not guaranteed, how can the upstart break through? Founded in 2011, United Imaging Healthcare is committed to providing global customers with a full range of independently developed high-performance medical imaging diagnostic and treatment equipment, life science instruments, and innovative solutions covering the entire chain of “basic research-clinical research-medical transformation”. Since its listing on the ...
- Source: drugdu
- 81
- September 6, 2024

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