media – Page 43 – DrugDu- Global Leading Pharmaceutical & Medical Device Platform

The application documents for the merger and reorganization of New Novartis have been accepted, accelerating the layout of the innovative drug track

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 ...
- Source: drugdu
- 84
- December 18, 2024
Xinda Biotech and Lilly have reached a cooperation agreement; Yuanda Pharmaceutical’s innovative ophthalmic drug NDA application accepted | Medical Early Reference

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, ...
- Source: drugdu
- 107
- December 18, 2024
RSV vaccine encounters black swan again

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 ...
- Source: drugdu
- 91
- December 18, 2024
New ADC hotspot emerges

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 ...
- Source: drugdu
- 68
- December 18, 2024
Biosafety Bill encounters setback again

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 ...
- Source: drugdu
- 82
- December 18, 2024
Oral peptides are on the rise

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 ...
- Source: drugdu
- 65
- December 18, 2024
【EXPERT Q&A】Can imported medical devices be commissioned to domestic third party production?

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 ...
- Source: drugdu
- 119
- December 18, 2024
Expopharm-Mexico

Organiser：Mexican Pharmaceutical Association Time：April 17th – 19th, 2025 Address：Conscripto 311, Colonia Lomas de Sotelo, Delegación Miguel Hidalgo, 11200, México D.F. Exhibition hall：Centro Banamex Product range: API Equipment: Reaction equipment, drying equipment, crystallization equipment, centrifuges, extraction equipment, heat exchangers, storage equipment, filtration equipment, evaporation equipment, distillation equipment, screening machinery, sterilization equipment, filter press equipment, homogenizers, etc. Pharmaceutical Preparation Equipment: Pill machinery, ointment machinery, eyedrop machinery, tablet machinery, tincture and syrup machinery, granule machinery, soft capsule machinery, aqueous injection machinery, hard capsule machinery, suppository machinery, oral liquid machinery, medicinal film machinery, aerosol machinery, antibiotic powder machinery, aqueous injection machinery, infusion machinery, tablet pressing machines, coating machines, medicinal filling machines, air jet mills, pharmaceutical grinding machines, mechanical pharmaceutical crushing machines, ultra-fine grinding machines, granulating machines, mixing equipment, bottle conveyors, bottle aligning machines, oscillating capping devices, feeding devices, etc. Pharmaceutical Packaging Machinery: Weighing equipment, bag packaging machines, pillow packaging machines, blister packaging machines, ...
- Source: drugdu
- 122
- December 17, 2024
2024 SABCS | Zhengda Tianqing Announces the Latest Data of Arrotinib Treatment for breast cancer

The 47th San Antonio breast cancer Symposium (SABCS) in 2024, held in the United States from December 10 to 13, is one of the largest and most prestigious academic events in the field of breast cancer research. At this conference, Zhengda Tianqing focused on HR+/HER2- and triple negative breast cancer, and released a number of clinical research data based on arotinib. The objective response rate (ORR) of the triple negative breast cancer study, which is called “the most toxic breast cancer”, is as high as 75.0%; The disease control rate (DCR) in the treatment of breast cancer patients with CDK4/6 inhibitor resistant HR+breast cancer was 94.9%. Efficacy and safety of the first-line treatment of advanced triple negative breast cancer with arotinib combined with paianzulimab and albumin bound paclitaxel: a prospective, phase II clinical study Forty three patients with inoperable locally advanced or recurrent/metastatic triple negative breast cancer (TNBC) with an ...
- Source: drugdu
- 116
- December 17, 2024
Maiwei Biotechnology and Chongqing High tech Zone Management Committee plan to invest 2 billion yuan in the construction of the “Bone Health Innovative Drug Project”

On December 16th, Shanghai Stock Exchange China Securities Network (Reporter Wang Mopujia) announced that Maiwei Biotechnology has signed a “Maiwei Biotechnology Bone Health Innovation Drug Project Contract” with the Chongqing High tech Industrial Development Zone Management Committee (referred to as “Chongqing High tech Zone Management Committee”) and the Chongqing Zhongxin Pharmaceutical Big Health Private Equity Investment Fund Partnership Enterprise (Limited Partnership) (referred to as “Big Health Fund”). Maiwei Biotechnology (Chongqing) Co., Ltd. (referred to as “Maiwei Chongqing”), a wholly-owned subsidiary of the company, will jointly invest in and construct the “Maiwei Biotechnology Bone Health Innovation Drug Project” as the project operating entity. It is reported that the total planned investment for the above-mentioned project is 2 billion yuan, of which Maiwei Biotechnology has a total investment of no less than 1.6 billion yuan (1.008 billion yuan in this round of investment), which will be contributed in the form of ...
- Source: drugdu
- 95
- December 17, 2024

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.