Qilu Pharmaceutical Files for Market Launch of Entrectinib Capsules, Targeting First-to-File Generic Status for Blockbuster Pan-Cancer Targeted Therapy with 875% Sales Surge
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
Ignyta
Drug Developer
Recently, according to the Mosun Medicine -- China Drug Evaluation Database,Qilu Pharmaceutical (Hainan)According to the Chemical Drug Registration ClassificationCategory 4DeclaredEntrectinib CapsulesThe listing application has been accepted. To date, there is no generic drug of this type approved in China.
Screenshot source: Mosan Medical China Drug Evaluation Database
EntrectinibIs able to penetrate the blood-brain barrierTRK/ROS1Tyrosine kinase inhibitor, byIgnytaOriginal Research. By the end of 2017,IgnytaByRocheAcquired for $1.7 billion. The drug's development progressed thereafter, and it received FDA approval for marketing in the U.S. on August 16, 2019. This drug has been hailed by the industry as a "star" targeted therapy that is not limited to specific cancer types. It is effective against 14 types of cancer and is the only clinically proven TRK inhibitor with efficacy for primary and metastatic brain diseases without adverse off-target activity.
Screenshot source: Mosentropy Global Drug R&D Database
July 26, 2022RocheUnder its umbrellaEntrectinib CapsulesApproved in China for the treatment of advanced solid tumors. In December 2023, two of its indications were included in the National Medical Insurance Drug List, achieving rapid market expansion. After entering the medical insurance, domestic sales surged in 2023 across the entire hospital market.Entrectinib CapsulesSalesExceeding 130 million yuan, nearly 120 million yuan in 2024, a year-on-year increase of nearly 875%, and surpassing 90 million yuan in the first half of 2025, indicating huge market potential.
Screenshot source: Mosun Medicine All-Terminal Hospital Sales Database
As of now,Entrectinib CapsulesExcept for Roche's approval in China, no generic drugs have been approved in the country. In terms of the generic drug pipeline, there are onlyQilu PharmaceuticalSubmittedEntrectinib CapsulesTheThe listing application has been accepted, and if approved smoothly, it is expected to obtain the first domestic generic version of the drug in China.
Screenshot source: Mosan Medical China Drug Evaluation Database
Screenshot source: Mosan Medical Database
Since the beginning of this year,Qilu PharmaceuticalSubmitted marketing applications for 16 generic drugs, all of which are currently under review. Among them, there are no generic versions approved in China for 12 products. If Qilu Pharmaceutical receives approval smoothly, it will undoubtedly take the lead in the race for the first generic drug and seize the market opportunity.
Source of screenshot: Mosentropy Medical Database
Whether Qilu Pharmaceutical can continue to top the annual list of first generics by the end of the year is worth looking forward to!
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