Huadong Medicine Initiates Bioequivalence Trial for Olaparib, Joining Fierce Competition for a Blockbuster Drug

On April 14, Huadong Medicine launched the BE trial for the PARP inhibitor "Olaparib," becoming the fourth company in China to join the competition in the generic version of this blockbuster drug.

Source: Insight Database Mini Program

Last October, Qilu Pharmaceutical was the first to submit a marketing application for a generic version of Olaparib, officially launching competition in this field. Currently, including Qilu, two companies have submitted marketing applications, two companies have initiated clinical trials, and another eight companies have been approved for clinical trials.

Blockbuster Drug Sales Reached $2.348 Billion in 2021

Olaparib, developed by AstraZeneca, is the world's first approved PARP inhibitor. In 2014, olaparib was first approved by the FDA for marketing for patients with advanced ovarian cancer with BRCA mutations. Since then, its indications have continued to expand. It was approved for maintenance treatment of ovarian cancer in 2017; entered the breast cancer field in 2018, and was approved for BRCA-mutated metastatic breast cancer; in May 2020, it was approved for two indications within the same month, including a bevacizumab combination therapy and an indication for castration-resistant prostate cancer.

Olaparib is undoubtedly a blockbuster drug. Since its approval, its sales have continued to soar, and the launch of similar products has not shaken its dominance. According to the company's annual report, its global sales reached $2.348 billion in 2021, a year-on-year increase of 30%. Including milestone income from cooperative sales, the total revenue from Olaparib reached $2.748 billion.

Sales of Olaparib in 2021

Source: AstraZeneca Annual Report

In China, olaparib was initially approved for marketing in August 2018. It has now been approved for multiple indications, including maintenance treatment for platinum-sensitive recurrent ovarian cancer, first-line maintenance treatment for advanced ovarian cancer with BRCA mutations, and monotherapy for metastatic castration-resistant prostate cancer with BRCA mutations that has progressed after prior novel hormonal agent therapy.

In 2019, Olaparib was included in the Class B Medical Insurance Catalogue after a 61.8% price reduction through negotiations. In 2020, due to the approval of new indications, Olaparib once again participated in the medical insurance negotiations, with a further price reduction of 39.64%, expanding its indications within the scope of medical insurance payments. The latest medical insurance payment price is 102 yuan/150mg/tablet. However, it is regrettable that in the latest medical insurance negotiations in 2021, Olaparib failed to successfully include the new indication of metastatic castration-resistant prostate cancer (mCRPC) within the scope of medical insurance payments.

In AstraZeneca's 2021 annual report, the company also explicitly mentioned that the annual sales of Olaparib in emerging markets significantly increased (+41%). This growth was mainly driven by the inclusion of the drug's first-line treatment for BRCA-mutated ovarian cancer in China's 2021 updated medical insurance directory in March, which led to a rise in demand.

In China, 12 generic drug companies have already laid out their plans.

According to the CDE Patent Registration Platform, the compound patent for Olaparib expires in March 2024, the formulation patent expires in October 2029, and the use patent expires in November 2024. However, companies in China began laying out plans for the generic production of Olaparib as early as 2015, and to date, 12 companies have developed it.

According to the Insight database, Qilu Pharmaceutical has fired the first shot in the submission for marketing approval. This application was filed under a Category 3 patent declaration, meaning a commitment not to market the product before the patent expires. Xuantai Pharmaceutical is the second Chinese company to file for marketing approval, also submitting a Category 3 patent declaration without challenging AstraZeneca's drug patent. This indicates that generic versions of Olaparib will not enter the market too quickly, allowing AstraZeneca to continue leading in China’s PARP inhibitor market.

In addition, apart from Huadong Medicine, Kelun Pharmaceuticals has also initiated BE trials for Olaparib, while other eight enterprises, including Hansoh, CSPC, and Zhengdatianqing, have not yet registered to start BE trials.

The Competitive Landscape of Olaparib in China

Source: Insight Database Mini Program (http://db.dxy.cn/v5/home/)