December 15 Mabwell Biotechnology (688062) announced a preliminary announcement regarding its plan to issue H shares and list on the Hong Kong Stock Exchange. The announcement stated that in order to meet the funding needs for the company’s operational development, achieve sustainable growth, and enhance its level of internationalization, the company intends to issue H shares abroad and list on the main board of the Hong Kong Stock Exchange. The company will choose an appropriate time and issuance window to complete this task within the validity period of the shareholders’ meeting resolution. As of now, the company is actively discussing relevant matters concerning the H share issuance with related intermediary institutions, but specific details have not yet been finalized. The announcement emphasized that the review and approval process for the issuance and listing of H shares involves significant uncertainties, and investors should remain vigilant about this situation. In the first ...
Recently, the largest university hospital system in Europe, Paris Public Assistance Hospital (AP-HP), reached a comprehensive framework agreement with Siemens Healthineers, marking the first such cooperation between the two parties. It is reported that this collaboration aims to address France’s major healthcare challenges by jointly developing innovative solutions for chronic diseases, neurological and cardiovascular diseases, musculoskeletal disorders, and cancer. 01. Joining hands with the largest university hospital system in Europe The agreement was signed by Nicolas Revel, CEO of Paris Public Aid Hospital, Bernd Montag, CEO of Siemens Healthineers, and Hassan Safer Tebbi, Regional Head of Siemens Healthineers France, Belgium, and Luxembourg. It is understood that this is the first time that Paris Public Aid Hospital has carried out such a large-scale cooperation with an imaging company. This collaboration not only involves clinical research, but also encompasses systematic changes in healthcare service provision, utilizing advanced technology to adapt to the ...
According to the well-known anonymous workplace community Teamblind, Microsoft plans to lay off 10000 to 15000 employees in January 2025. Once this news was released, it immediately attracted widespread attention from all sectors of society. If the layoff plan is confirmed, it will not only have a significant impact on Microsoft itself, but also affect the entire technology industry. According to insiders, Microsoft’s compensation plan for this round of layoffs may follow the old practice of the “N+2” model. At present, the specific departments involved in the layoff plan and whether it covers the China region are not yet clear. This has increased speculation from the outside world about Microsoft’s future strategic adjustments. Layoffs are usually related to a company’s business restructuring, cost reduction, or strategic transformation, and Microsoft’s move may indicate significant adjustments in certain business areas. It is worth noting that as a tech giant with years of ...
After nearly a year of planning, there have been new developments in the restructuring of New Novartis. Xinnuowei recently announced that the company has received a notice from the Shenzhen Stock Exchange regarding the acceptance of the application documents for the issuance of shares to purchase assets and raise supporting funds by Shiyao Innovation Pharmaceutical Co., Ltd. The Shenzhen Stock Exchange has verified the application documents submitted by the company for the issuance of shares to purchase assets and raise supporting funds, and considers them complete. Therefore, the company has decided to accept them. However, behind this restructuring plan, both New Novartis and its target company, Shiyao Group Baike (Shandong) Biopharmaceutical Co., Ltd. (hereinafter referred to as “Shiyao Baike”), are facing significant performance challenges that cannot be ignored. In the first three quarters of 2024, New Norwe experienced a double decline in revenue and net profit, with a year-on-year decrease ...
NO.1 Xinda Biotech and Eli Lilly reach commercial cooperation on third-generation BTK inhibitors On December 16th, Xinda Biotechnology and Eli Lilly and Company Limited jointly announced the following cooperation agreement regarding the rights and interests of Eli Lilly and Company Limited’s non covalent (reversible) BTK inhibitor “Jepanib” (100mg and 50mg tablets of Pitobutinib): Xinda Biotechnology will be responsible for the import, sales, promotion, and distribution of “Jepanib”, while Eli Lilly and Company Limited will be responsible for the research and development of “Jepanib” and post marketing medical affairs. This drug is the latest generation, the world’s first and only approved non covalent (reversible) BTK inhibitor. Comment: Eli Lilly and Company is a long-term partner of Xinda Biotechnology. In the past 10 years, the two parties have reached 5 cooperation agreements. The promotion of this cooperation can not only enable Xinda Biotechnology to obtain cash flow and enrich its own pipeline, ...
Another “black swan” event in the field of RSV vaccines. On December 10, the FDA announced a comprehensive suspension of all RSV vaccine research for infants and young children, including research on Moderna’s two vaccines mRNA-1345 and mRNA-1365, and plans to hold an advisory committee meeting on the 12th to discuss the safety of the vaccine. Among them, mRNA-1345 was approved by the FDA in May for the prevention of RSV in the elderly over 60 years old. mRNA-1345 was once regarded as a strong competitor to the two RSV vaccines, GSK’s Arexvy and Pfizer’s Abrysvo. However, on June 26, Moderna released data showing that its efficacy dropped to about 50%. Affected by this news, Moderna’s stock price plummeted 11%. At present, the briefing document released by the FDA reveals a more unfavorable information for Moderna: clinical data show that RSV infection is seriously different between the vaccine group and ...
ROR1 ADC shines at ASH Annual Meeting. At ASH Annual Meeting, Merck announced the results of Phase II study of ROR1 ADC drug zilovertamab vedotin: in the first-line treatment of diffuse large B-cell lymphoma (DLBCL) patients, the 1.75mg/kg combination therapy dose group achieved 100% complete remission (CR). This result has triggered speculation that ROR1 ADC may reshape the treatment landscape of DLBCL. At the same time, CStone Pharmaceuticals announced that the ROR1 ADC drug CS5001 showed positive data in advanced B-cell lymphoma that had been treated in multiple lines. The overall objective response rate (ORR) for Hodgkin lymphoma (HL) reached 60%, and all three evaluable HL patients in the 8th dose group achieved complete or partial remission. If this trend can be maintained in the future, CS5001 is expected to reshape the landscape of late-line treatment of Hodgkin lymphoma. For non-Hodgkin’s lymphoma including DLBCL, the ORR was as high as ...
The Biosafety Bill, which the biotech industry is most worried about, has made new progress. On December 7, the shoe finally dropped: the relevant provisions of the Biosafety Bill did not appear in the final negotiation text of the 2025 National Defense Authorization Act (“NDAA”) after consultation by members of the Senate Armed Services Committee. This shows that the attempt to include the Biosafety Bill in the 2025 NDAA has failed, and it will not pose an obstacle to the overseas expansion of companies such as BGI in the short term. This is the case in the short term, and it is likely to be the case in the long term. In the eyes of the market, this is not the end, and there is still a possibility of being mentioned again in the future. This is the case in theory, but in fact, the “abortion” of the Biosafety Bill ...
Next, let’s turn our attention to the international stage and first focus on AbbVie’s latest merger and acquisition. On December 13, AbbVie announced that it would acquire privately held company Nimble Therapeutics for $200 million in cash, targeting a preclinical development of an investigational oral peptide IL23R inhibitor for the treatment of psoriasis, as well as other new oral peptide products for various autoimmune diseases. This also highlights a trend that the oral peptide market is beginning to rise in the autoimmune treatment market. In the field of oral peptide IL23R inhibitors, there was good news in November: Johnson & Johnson announced that the ICONIC-LEAD clinical study obtained top-line results, which means that the world’s first targeted oral peptide Icotrokinra that selectively blocks IL-23 receptors will soon be on the market. From a clinical positioning perspective, oral peptide drugs are a good supplement to injectable preparations due to their compliance ...
Drugdu.com expert’s response: The direct commissioning of domestic third-party production for imported medical devices is not permitted. This regulation is primarily based on the stringent quality control and regulatory requirements for medical device production. Due to the differences in medical device regulatory systems across different countries and regions, directly commissioning domestic third-party production may pose risks in terms of quality and regulation. However, the registrant of imported medical devices can produce Class II and Class III medical devices that have already obtained imported medical device registration certificates within China through a foreign-invested enterprise established within the territory. This approach requires meeting certain conditions, such as no changes to the product design and maintaining a consistent quality system, to ensure that there are no significant changes to the safety and effectiveness of the products. Additionally, the original imported registration certificate must be valid; if it has expired or been cancelled, it ...
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