Nanjing Zhengda Tianqing Enters Race for Novartis' $2B Blockbuster with Generic Sacubitril/Valsartan Filing

On September 18, Chia-Tai Tianqing submitted a Class 4 generic marketing application for Sacubitril/Valsartan Sodium Tablets. This product is a blockbuster heart failure drug from Novartis. Currently, the Chinese market only has the imported innovator drug. Previously, eight domestic pharmaceutical companies have already filed for generic marketing approval, and the competition for the first domestic generic approval is intensifying.

Figure 1: Product Information of Chia Tai Tianqing's Latest Submission

Source: CDE Official Website

Sacubitril/Valsartan Sodium Tablets, developed by Novartis, is an angiotensin II receptor blocker. In 2020, global sales of the originator product reached US$2.497 billion, placing it among blockbuster drugs. The originator product was approved for the Chinese market in 2017 for adult patients with chronic heart failure with reduced ejection fraction to reduce the risk of cardiovascular death and heart failure hospitalization. It was successfully included in China's National Reimbursement Drug List through negotiations in 2019 and remains currently within its validity period.

Figure 2: Sales of Novartis Sacubitril/Valsartan Sodium Tablets in the Retail Market (Unit: 10,000 RMB)

Source: MENET China Urban Physical Pharmacy Database

Data from Menet shows that in 2020, sales of Novartis' sacubitril/valsartan sodium tablets at the terminals of urban public hospitals, county-level public hospitals, urban community health centers, and township health clinics (collectively referred to as China's public medical institutions) exceeded RMB 500 million. Meanwhile, at urban physical pharmacy terminals in China, sales have grown rapidly in recent years, surpassing RMB 260 million in 2020. With the progressive implementation of the "dual-channel" medical insurance policy across various provinces, the incremental sales of this product in the retail market are expected to see further growth.

Table 1: Status of Previously Submitted Marketing Authorization Applications Under Review

Source: MENET MED 2.0 China Drug Evaluation Database

The robust sales of the originator product in both the global and Chinese markets have attracted the attention of numerous domestic pharmaceutical companies. To date, eight companies have submitted Class 4 generic marketing applications, which are currently under regulatory review. Based on the acceptance dates, Shanghai Xuantai Haimen Pharmaceutical | Nanjing Yixinhe Pharmaceutical Technology were the earliest to file for marketing approval in 2018, followed by domestic companies such as CSPC, Chia-Tai Tianqing Pharmaceutical Group, Salubris, and Chengdu Bright Gene Pharmaceutical, which subsequently entered the race. Sichuan Kelun and Nanjing Chia-Tai Tianqing filed their applications this year, and the corresponding acceptance numbers are currently under review and approval. The competition for the first generic approval of Sacubitril/Valsartan Sodium Tablets in China is becoming increasingly fierce.

Source: CDE Official Website, MENET Database

Review data statistics are as of September 22. Please point out any errors or omissions.