PharmaFocus Today – Page 96 – media

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
- 201
- 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
- 127
- 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
- 104
- 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
- 112
- 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
- 98
- December 18, 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
- 174
- 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
- 167
- December 17, 2024
Anjisheng Biotechnology completes $120 million Series C financing

On December 11th, Angitia announced the completion of a $120 million Series C funding round led by Bain Capital Life Sciences. The participants in this round of investment include new investor Janus Henderson and existing shareholders Aobo Capital, Sanzheng Health Investment, Yonghua Investment, Junlian Capital, and Lichen Investment. According to the press release, the proceeds from Series C financing will be used to support Anjisheng’s innovative drug pipeline, dedicated to developing differentiated and innovative treatment plans for critical bone, joint, and muscle diseases. Anjisheng Biotechnology is an innovative drug research and development company specializing in the field of severe diseases of bones, joints, and muscles. Currently, three biopolymer candidate drugs are in the clinical research stage, aimed at treating osteoporosis, osteogenesis imperfecta (OI), and spinal fusion. Among them, the company is advancing the global clinical development of AGA2118 and AGA2115 for the treatment of osteoporosis and osteogenesis imperfecta (OI). These ...
- Source: drugdu
- 151
- December 17, 2024
Interventional valve surgery robot completes Series C financing

According to the Medicine Intelligence Data Investment Pattern Database, Capstan Medical, a robotics company specializing in interventional valve surgery, recently announced the successful completion of its Series C financing, raising a total of $110 million (contract amount of RMB 800 million). This round of financing is led by Eclipse, with existing investors such as Yu Galaxy and Intuitive Ventures participating, while introducing new investor Gideon Strategic Partners. It is reported that the funds raised in this round are intended to be used to bring its robot assisted minimally invasive solution to the market to solve heart valve diseases. In addition, according to the Pharmaceutical Intelligence Data Investment Pattern Database, Capstan Medical has completed two rounds of financing, with the last round being the B-round financing completed on August 9, 2023, raising a total of 31.4 million US dollars (contract 230 million RMB). Valve disease (VHD) is a structural heart disease ...
- Source: drugdu
- 159
- December 17, 2024
Liu Yongjun resigns from CSPC

Liu Yongjun resigned at the speed of light. On December 9, according to media reports, Liu Yongjun had resigned from CSPC, just three months after the official announcement of joining. On September 9 this year, CSPC issued an announcement on the Hong Kong Stock Exchange, announcing the appointment of Liu Yongjun as the group’s executive president and global R&D president, responsible for the group’s R&D, pipeline strategy and international business development. It may be rare in the industry for a senior executive in this position to resign within three months. Combined with a series of personnel, capital and innovation strategy changes from CSPC to its innovative pharmaceutical subsidiary in the past three months, it can be seen that CSPC may be facing certain challenges in innovation, R&D, and internationalization. This also highlights the fact that the transformation of most traditional pharmaceutical companies may end in failure. After all, innovation cannot ...
- Source: drugdu
- 144
- December 17, 2024

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