The Third Domestic Company: Kelun Pharmaceuticals Submits a Listing Application for 'Olaparib'

On September 8, according to CDE's officialwebsite, Kelun Pharmaceuticals submitted a marketing application for Olaparibcategory 4 generic drugs (acceptance number: CYHS2201475). This is the thirdOlaparib generic drug that has been declared for listing in China. Since lastyear, the domestic generics of Olaparib have been active frequently, and theimitation competition of this blockbuster variety is about to begin.

 Pic.1 CDEofficial website

Olaparib, developed by AstraZeneca, is theworld's first approved PARP inhibitor. In 2014, Olaparib was first approved bythe FDA for patients with BRCA-mutated advanced ovarian cancer. Since then, itsindications have continued to expand, and it was approved for ovarian cancermaintenance therapy in 2017; it entered the field of breast cancer in 2018 andwas approved for BRCA-mutated metastatic breast cancer; in May 2020, twoindications were approved within the same month, including A bevacizumabcombination therapy, and indication for castration-resistant prostate cancer.

Olaparib is a well-deserved blockbusterdrug. Since its approval, its sales have continued to soar, and the successivelisting of similar products has not shaken its kingship. According to thecompany's annual report, its global sales in 2021 have reached US$2.348billion, a year-on-year increase of 30%. Including co-sales milestones, totalrevenue from Olaparib reached $2.748 billion.

In China, Olaparib was initially approvedfor marketing in August 2018 and has been approved for multiple indications,including maintenance therapy for platinum-sensitive recurrent ovarian, fallopiantube or primary peritoneal cancer, BRCA-mutated Monotherapy for first-linemaintenance therapy for advanced ovarian, fallopian tube, or primary peritonealcancer, BRCA-mutated metastatic castration-resistant prostate cancer that hasprogressed on prior novel hormonal therapy.

In 2019, Olaparib negotiated a pricereduction of 61.8% and entered the category B category of medical insurance. In2020, due to the approval of new indications, Olaparib participated in themedical insurance negotiation again, and reduced the price by 39.64% to expandnew indications within the scope of medical insurance payment. The latestmedical insurance payment price is 102 yuan/150mg/tablet. Unfortunately, in thelatest medical insurance negotiation in 2021, Olaparib failed to successfullyinclude the new indication of trend-resistant prostate cancer (mCRPC) into thescope of medical insurance payment.

AstraZeneca mentioned in both the 2021annual report and the 2022 semi-annual report that the annual sales of Olaparibin emerging markets have increased significantly. This growth is mainly due tothe inclusion of the drug's first-line indications for BRCA-mutated ovariancancer into China The new version of the medical insurance catalogue in 2021will bring about an increase in demand.

However, domestic generic drugs have longbeen eyeing this blockbuster variety. According to the Insight database,domestic companies have begun to deploy Olaparib generic drugs as early as2015, and there are currently 3 applications for listing, from Qilu, Xuantai,and Kelun, of which Qilu was the first to be deployed in October last year. Thelisting application has been submitted; 5 companies have launched BE trials,and 8 companies have been approved for clinical use.

According to the CDE patent registrationplatform, the compound patent of Olaparib expires in March 2024, theformulation patent expires in October 2029, and the use patent expires inNovember 2024. However, domestic companies have begun to deploy Olaparibgeneric drugs as early as 2015, and 12 companies have developed them so far.