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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
- 113
- 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
- 93
- 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
- 73
- 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
- 117
- 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
- 98
- 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
- 100
- 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
- 95
- 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
- 77
- September 9, 2024
【EXPERT Q&A】Why domestic medical device bidding needs CE certification?

Drugdu.com expert’s response: The reasons for requiring CE certification in domestic medical device tenders can be elaborated from multiple perspectives: Ⅰ. International Recognition and Market Access of CE Certification International Recognition: CE certification is a prerequisite for market access in Europe. Medical devices with CE certification must comply with European standards such as EN60601 and EN45545. This signifies that CE certification not only enjoys a high level of recognition in the European market but is also globally recognized as an important indicator of product quality and safety. Market Access: For medical device manufacturers aiming to enter the European market, CE certification is indispensable. Without the CE mark, it is illegal to sell or distribute medical devices within the European Economic Area. Therefore, requiring CE certification for domestic medical devices in tenders helps enhance their competitiveness in international markets. Ⅱ. Enhancing Product Quality and Safety Quality Improvement: To obtain CE certification, ...
- Source: drugdu
- 68
- 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
- 124
- September 7, 2024

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