PharmaFocus Today – Page 91 – media

The world’s first! Kangfang Biological Double Anti First Line Treatment for NSCLC Defeats K-Drug

On September 8, 2024, Kangfang Biotechnology announced at the 2024 World Lung Cancer Congress the heavyweight research data of the registered Phase III clinical trial (HARMONI-2/AK112-303) of the company’s independently developed global first PD-1/VEGF bispecific antibody new drug, Ivoxidan, compared to pembrolizumab monotherapy for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with PD-L1 expression positive (PD-L1 TPS ≥ 1%). Ivoxidan became the world’s first drug to demonstrate significantly better efficacy than pembrolizumab in a single drug head to head Phase III clinical trial. Affected by this news, the stock price of Kangfang Biotechnology has risen by 14%. AK112-303/HARMONI-2 (CTR20222137) is a registered phase III randomized, double-blind clinical trial conducted in China to evaluate the first-line treatment of locally advanced or metastatic NSCLC with PD-L1 expression positive (PD-L1TPS ≥ 1%) compared to Ibuprofen (PD-1/VEGF) monotherapy. The primary endpoint was PFS assessed by IRRC according to ...
- Source: drugdu
- 135
- September 11, 2024
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
- 115
- 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/
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- September 11, 2024
cochlear implants and other high-value medical supplies will be included in the scope of collection and procurement

September 10, 2011 – The State Council Information Office held a series of press conferences on the theme of “promoting high-quality development” on the morning of the 10th, Yan Qinghui, deputy director of the State Medical Insurance Bureau, said at the meeting that the medical insurance sector will vigorously promote the expansion of the quality of the collection of medicine and mining. Continuously expand the coverage of collection, carry out a new batch of national organization drugs and high-value medical supplies collection, will be cochlear implants and other high-value medical supplies into the collection. Yan Qinghui introduced, the effectiveness of the collection work can be recognized from three aspects: First, the burden of drug use by the public has been reduced, and the accessibility and quality of drugs have been improved. For example, hepatitis B antiviral drugs entecavir and tenofovir, etc., the annual cost of patients before the ...
- Source: https://finance.eastmoney.com/a/202409103179908838.html
- 197
- 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
- 180
- September 11, 2024
Plant intervention at the forefront, terminate IPO!

On September 4th, the Shanghai Stock Exchange terminated one IPO company: Shandong Branden Medical Equipment Co., Ltd. (hereinafter referred to as “Branden”). According to information, this was Branden’s voluntary withdrawal of its listing application, and the listing on the Science and Technology Innovation Board was terminated. Two major products support the banner of revenue Founded in 2003, Baibai An is a national high-tech enterprise dedicated to applying medical material modification technology to implantable medical devices, focusing on the research and development, production, and sales of biological and medical products. Through independent research and continuous innovation, Branden has formed a technology platform centered on medical material modification, precision machining, and digital diagnosis and treatment of vascular pathways. According to the prospectus, Branden is the first domestic enterprise to obtain the registration certificate for Class III medical device products of domestically produced Peripherally Inserted Central Catheters (PICCs), breaking the monopoly of imported ...
- Source: drugdu
- 187
- September 9, 2024
CPC releases the first miniature sterile connector suitable for low-temperature applications in the cell and gene therapy industry

On September 5, 2024, Colder Products Company (CPC) launched a new sterile micro connector, which is the first connector that can be directly loaded into a freezer and is used in cell and gene therapy (CGT) processes. The MicroCNX ® ULT series can be frozen to -190 ° C and is compatible with the most commonly used types of tubing for developing cutting-edge therapies, including polyvinyl chloride (PVC) tubing. In order to meet the needs of cell viability, shelf life, and transportation, many cell therapy processes are lowered to a temperature range of -150 º C or lower, “said Troy Ostreng, Senior Product Manager of CPC Biopharmaceutical Business. The MicroCNX ® ULT connector is designed to provide a simple and efficient method for achieving sterile connections in pipelines used for small cell therapy and gene therapy components. This connector does not require additional piping in the process, thus helping to ...
- Source: drugdu
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- September 9, 2024
Up to 1 billion US dollars! An RNA pharmaceutical company has reached a cooperation agreement with Eli Lilly

On September 4, 2024, HAYA Therapeutics, a pioneering biotechnology company that uses precise RNA guidance to regulate genome targeting therapy for chronic diseases, announced the signing of a multi-year cooperation agreement with Eli Lilly. Both parties will utilize HAYA’s advanced RNA guided regulatory genome platform to support preclinical drug discovery for obesity and related metabolic diseases. The partner will identify multiple RNA targets derived from the regulatory genome to treat these chronic diseases. According to the terms of the cooperation agreement, HAYA will receive a down payment, including equity investment, and is eligible to receive up to $1 billion in preclinical, clinical, and commercial milestone payments, as well as royalties for product sales. HAYA’s proprietary regulatory genome discovery platform can identify long non coding RNA (lncRNA) targets specific to tissues, diseases, and cells, and develop treatment methods targeting RNA, which may have better efficacy and lower toxicity compared to current ...
- Source: drugdu
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- September 9, 2024
Vaxcyte’s stock price soared after achieving a ‘stunning’ victory in the competition against Pfizer’s 31 valent pneumococcal conjugate vaccine (PCV)

Editor’s Bio Products Circle Vaxcyte has released Phase 1/2 data for its 31 valent pneumococcal vaccine candidate, which analysts have described as “astonishing”. If these data can be replicated in large-scale critical studies, it could pose a serious threat to Pfizer’s Prevnar 20. Vaxcyte’s half period data for VAX-31 in adults aged 50 and above against Prevnar 20 is “extraordinary” and suggests a “killer product in the pneumococcal conjugate vaccine category,” said analysts at Leerink Partners in a report on Tuesday. Leerink analyst said, “We believe that these data support VAX-31’s potential to gain a significant market share in the pneumococcal conjugate vaccine market expected to exceed $10 billion by 2030+ Due to this positive reading, Mizuho analysts referred to it as the “best case scenario,” and Vaxcyte’s stock price jumped about 44% at the release time on Tuesday morning.Today, we are opening a new chapter for Vaxcyte as we ...
- Source: drugdu
- 156
- September 9, 2024
Subsidiary Cefazoxime Sodium for Injection Passed Consistency Evaluation of Generic Drugs

Lionco Pharmaceuticals (603669) September 5 evening announcement, recently, the company’s subsidiary Lionco Pharmaceuticals received the State Drug Administration issued “Cefzodoxime Sodium for Injection” supplemental application for approval of the notice of the drug, the drug through the generic quality and efficacy consistency evaluation. As of the date of the announcement, the Company has invested RMB5.72 million in research and development for Cefozoxime Sodium for Injection. The drug is mainly used for lower respiratory tract infections, urinary tract infections, abdominal infections, pelvic infections, sepsis, skin and soft tissue infections, bone and joint infections, meningitis caused by Streptococcus pneumoniae or Haemophilus influenzae, and simple gonorrhea caused by sensitive bacteria. According to IMS data, the China market sales of cefazoxime sodium for injection is 2,740 million yuan in 2023. According to the State Drug Administration (SDA), a total of 34 companies (including Lingkang Pharmaceuticals) have been approved to market cefzodoxime sodium for injection ...
- Source: drugdu
- 122
- September 9, 2024

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