Note: The "cumulative revenue of $123 billion contributed by MSD in the first three quarters of this year" in the video refers to "sales as of the first three quarters of 2024."The Core Patent of "King of Drugs" Pembrolizumab is About toExpires in 2028,As the patent cliff approaches, pharmaceutical companies in and outside China are making efforts to develop biosimilars of K drug.As one of the most significant products in the field of oncology, Keytruda (K药) successfully claimed the throne as the top-selling drug with $25 billion in sales in 2023. As of the first three quarters of 2024, it has alreadyCumulatively contributed $123 billion to Merck.Yuan of income. For pharmaceutical companies, this is undoubtedly a big piece of meat.
Source: Insight Database
Currently GlobalMore than 20 K drug biosimilars are under development., among whichNine products have entered Phase III clinical trials., the competition is still very fierce.By contrast, there are only 4 drugs under research in China, respectively from Qilu Pharmaceutical.（QL2107）, Bio-Thera（BAT3306）、Henlius（HLX17）and Zhangjiang Bio（CMAB820）。Henlius(Approved for clinical use)And Zhangjiang Bio(Phase I Clinical)It is still in the early clinical stage, andQilu Pharmaceutical and Bio-Thera Have Advanced to Phase III Clinical Trials, The first domestic generic is basically locked in these two companies.Qilu Pharmaceutical（QL2107）A Chinese Phase III clinical trial for the treatment of non-squamous non-small cell lung cancer was registered in December 2024. According to the Insight database's review duration prediction function, we found that biosimilars of monoclonal antibodies require an average of 1,035 days from pivotal clinical trials to final market approval. Based on this estimate, Qilu Pharmaceutical（QL2107）Expected to be approved in Q4 2027。Bio-Thera（BAT3306）The international multi-center Phase I/III clinical trial for the same indication was initiated in February 2024, with key results expected to be available by July 2027. If the progress is smooth,Launch in 2028 or even earlierIt is still very promising.In other words, the first biosimilar of K drug is most likely to be launched by the end of 2027 or early 2028, between Qilu Pharmaceutical and Bio-Thera. Although the race for the first generic is almost determined, the field as a whole is not yet crowded, and there are still opportunities for latecomers.Cover Source:ZCOOL Hello
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