PharmaFocus Today – Page 43 – media

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
- 66
- September 9, 2024
Spending 1.3 billion, Sinopharm Group strikes again

Recently, Tiantan Biological announced that its holding subsidiary Chengdu Rongsheng Pharmaceutical Co., Ltd. intends to acquire 100% equity of Wuhan Zhongyuan Ruide Biological Products Co., Ltd., a wholly-owned subsidiary of CSL BEHRING ASIA PACIFIC LIMITED (Jetbehring (Asia Pacific) Co., Ltd.) for a total amount of US$185 million (nearly RMB 1.33 billion). Among them, the equity acquisition price is US$138 million, and the remaining amount is provided by Chengdu Rongsheng to Zhongyuan Ruide to repay the shareholder loan of CSL Asia Pacific to Zhongyuan Ruide (hereinafter referred to as “CSL”, “Zhongyuan Ruide” and “this acquisition”). After the completion of this transaction, Zhongyuan Ruide will become a holding subsidiary of Tiantan Biological, and its financial statements will be consolidated. For Tiantan Biological, this is a deal that adds icing on the cake. Blood products are a rigid demand track with extremely high barriers, and “whoever gets the plasma station will win the ...
- Source: drugdu
- 78
- September 9, 2024
Secondary bargaining “liberalized”

Secondary bargaining will become an important tool for price governance. In a broad sense, secondary bargaining refers to the second price negotiation between the buyer and the seller during the transaction process, outside the established bargaining results. Specifically at the drug procurement level, it is the act of the purchasing units below the provincial level (such as cities, medical communities/medical alliances, hospitals, etc.) initiating bargaining with suppliers again outside the mainstream provincial drug prices. Although secondary bargaining has always been controversial, the behavior of hospitals in secondary bargaining is very common in the industry. The reasons are as follows: First, there is no prohibition in major policies. At the national level, it is only clear that secondary bargaining is not allowed for drugs selected in centralized procurement. For ordinary drugs listed on the Internet, price governance itself is a process in which multiple parties participate in the formation of a ...
- Source: drugdu
- 76
- September 9, 2024
Chinese neurological device giant rushes for IPO

Recently, Beijing Pinchi Medical Equipment Co., Ltd. (hereinafter referred to as “Pinchi Medical”) completed the listing guidance registration and planned IPO at the Beijing Securities Regulatory Bureau, and the guidance institution is CICC. According to the counseling work arrangement, CICC plans to complete the counseling plan for Pinchi Medical in November and December this year, and apply to the Beijing Securities Regulatory Bureau for counseling acceptance. After the counseling is completed and accepted, Pinchi Medical may apply for an IPO. This is another brain pacemaker company that plans to go public through an IPO in 2023 after Jingyu Medical started filing for listing counseling. According to Smart Medical Equipment, so far, the only two local companies that mass-produce brain pacemakers have embarked on the road to IPO. Founded in 2008, Pinchi Medical is a high-tech enterprise specializing in the research and development, production and sales of a series of neuromodulatory ...
- Source: drugdu
- 69
- September 9, 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
- 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
- 75
- 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
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
- 83
- 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

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