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MABPHARM-B (02181.HK): The Indonesian Food and Drug Authority has approved the marketing authorization for the core product CMAB008 (infliximab injection).
On December 27, Gelonghui announced that MABPHARM-B (02181.HK) has recently obtained approval from the Indonesian Food and Drug Administration for the marketing license of its core product, the self-developed recombinant anti-tumor necrosis factor α ("TNFα") human-mouse chimeric monoclonal antibody CMAB008 (infliximab for injection), for the treatment of: (i) adult ulcerative colitis; (ii) ankylosing spondylitis; (iii) rheumatoid arthritis; (iv) Crohn's disease in adults and children over 6 years old; (v) fistulizing Crohn's disease; and (vi) psoriasis.
Express News | Mabpharm - Approval From Indonesian National Agency of Drug and Food Control on Marketing Authorization of Cmab008 (Infliximab for Injection)
Highly resilient! Leading CRO companies have stabilized their fundamentals, but the shadow of the biosafety bill may still linger next year | Year-end review.
① In 2024, the USA Biodefense Act will disrupt CROs throughout the year and may continue next year; ② In the first three quarters of this year, over half of listed companies experienced revenue growth, and leading CROs demonstrated resilience; ③ Research on popular targets such as ADC, GLP-1, and bispecific antibodies will continue to be hot; ④ In 2025, the performance of leading CROs and small to medium enterprises may further diverge.
Lacklustre Performance Is Driving Mabpharm Limited's (HKG:2181) 25% Price Drop
The U.S. bioterrorism law has undergone significant changes, the CRO concept has launched a major counterattack, and WuXi AppTec is excited!
Industry pessimistic expectations may improve.
How to break through the challenges in the development of innovative drugs? The industry suggests focusing on internationalization.
① The year 2024 will be the inaugural year of large-scale authorized trade, and going abroad has become an important direction for the development of local pharmaceutical companies; ② Chinese企业品牌, clinical trial capabilities, data presentation formats, and levels of international operation still need time and practical verification.