Originator Exited, Qilu Ascends: Oxaliplatin Injection Gains Reference Status Amid Regulatory Shift
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
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On July 15, the official version of the second batch of the "List of Reference Preparations for Removal" was released.
Injection with Oxaliplatin, which was included in the draft for comments as early as September 2023, has finally been settled and confirmed to be removed.
This means that there is currently no reference preparation for injectable oxaliplatin, and the generic pathway for lyophilized powder injections has been officially cut off.
As the third-generation platinum-based antineoplastic drug, oxaliplatin has two types of formulations in China: true solution and freeze-dried powder. Its reference status, however, has experienced several reversals —
From replacing lyophilized powder with true solutions, to the exclusion of the original research product from the reference list, while the generic products were included instead....
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OxaliplatinThe earliest dosage form was lyophilized powder injection, developed by Sanofi in 19Launched in France in 1996, entered the Chinese market in 1999. In the early days, there were many domestically produced products available in China, including those from Aosaikang, Hengrui, and Yangzijiang.For many years thereafter, freeze-dried powder remained the mainstream dosage form in China.
In 2005,Sanofi has launched another solution formulation in the United States.Oxaliplatin Injection, but this dosage form has never entered the Chinese market.
In 2020, Sanofi's lyophilized powder was listed as a reference. Meanwhile, one month later,The true solution also announced the reference, but it was not Sanofi's original product, but Qilu Pharmaceutical's generic product launched in the United States in 2016.
The original drug didn't make it, but the generic did. The reason given was also clear: Sanofi's Oxaliplatin Injection sterilization method does not comply."Guiding Principles for Research and Validation of Sterilization and Aseptic Processes for Chemical Injectable Agents (Trial)", not eligible for reference.
The status of a reference preparation has never been solely about "original research," but rather whether it holds the position of a reference.For Oxaliplatin Injection, the original research drug was excluded, leaving domestically produced generics.
What about Qilu Pharmaceutical's products? How are they improved over the original research?
According to Qilu Pharmaceutical Co., Ltd.Disclosure, itsThe oxaliplatin injection is manufactured byTerminal high-temperature sterilization,The National Medical Products Administration (NMPA) has explicitly stated in both the "Basic Technical Requirements for Chemical Injectable Agents" and the "Guiding Principles for Sterilization/Aseptic Process Validation" that,Injectable preparations should primarily adopt high-temperature sterilization processes, which provide a higher level of sterility assurance; for those unable to withstand terminal sterilization processes, filtration sterilization or aseptic processing can be considered.
The core difference is speculated to be whether terminal sterilization is applied; Qilu Pharmaceutical has made improvements to the original research product rather than replicating it exactly.
In contrast, there are significantly more companies applying for injectable solutions, including leading enterprises like Hengrui and Huiyu. A relatively large number of these companies have successfully passed the evaluation, and the progress is much faster than that of freeze-dried powder.
Looking at the market side again,The market for injectable oxaliplatin is not small,Before 2021, it once broke through 3 billion yuan, with the original research Sanofi accounting for more than 90%.
Until 2021Oxaliplatin InjectionIncluded in the fifth batch of national procurement, the freeze-dried powder was exclusively awarded to Sanofi. This is also one of the few cases where an original research company has won a national procurement bid.
But the price compression brought by centralized procurement still makes the market decline inevitable.As the fifth batch of national procurement agreements expire in 2024, freeze-dried powder will not be renewed and will no longer be affected by centralized procurement, leaving the marketOnly 1.5 billion left, Sanofi still holds 90% of the market。
By contrast, both oxaliplatin injection and lyophilized powder participated in the fifth batch of centralized procurement. However, after the agreement period ended, they successfully completed the renewal process, retaining their eligibility, which means they will gain a solid foothold in the new round of market redistribution.
CurrentlyOxaliplatin Injection has been approved by eight companies, and the centralized procurement renewal is ongoing.FutureThe three major winning companies: Hengrui, Qilu,Huiyu Will Gradually Erode the Remaining 1.5 Billion Market for Lyophilized Powder。
A 1.5 billion market is being re-divided. The winner and loser have, in fact, long been decided.
All screenshots in this article are from: Mosentropy Medicine
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