Search Results for “Clinical Trial” – Page 45 – media

635 million US dollars! Anmai Biological BCMA × CD3 Double Antibody Successfully Goes to Sea

Anmai Biotechnology announced that it has reached a licensing agreement with Vignette Bio for the T cell conjugation (TCE) molecule EMB-06 targeting BCMA. 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 Biotechnology’s internal new drug ...
- Source: drugdu
- 59
- September 11, 2024
The first domestic new drug for alopecia areata is about to be launched

Recently, Hengrui Medicine announced that its application for marketing authorization of emasitinib sulfate tablets (SHR0302 tablets) was accepted by the National Medical Products Administration for the treatment of severe alopecia areata in adults. It is the first domestic JAK inhibitor to be accepted for marketing approval for alopecia areata indications in China. This also means that after Eli Lilly and Pfizer products have been approved in China, Hengrui is likely to become the first domestic company to enter the domestic alopecia areata market. Severe alopecia areata in adults is the fourth indication reported by emasitinib. Last year, it also reported moderate to severe atopic dermatitis, ankylosing spondylitis, and moderate to severe active rheumatoid arthritis in adults and adolescents aged 12 and above. Referring to the progress of Pfizer’s application for listing of Litixitinib Capsules accepted by the National Medical Products Administration in September 2022, included in the ...
- Source: https://mp.weixin.qq.com/
- 77
- September 11, 2024
Novo Nordisk applies for listing of growth hormone in China once a week

Today, 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. Screenshot source: CDE official website 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 ...
- Source: drugdu
- 70
- September 11, 2024
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
- 95
- 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
- 62
- 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
- 65
- 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
- 54
- 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
- 54
- 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
- 58
- 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
- 73
- September 6, 2024

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