Pfizer's $1B Sunitinib Malate Faces Fierce Competition as Four Chinese Pharma Giants Race for First Generic

Recently, Qilu Pharmaceutical’s marketing application for sunitinib malate capsules was accepted. According to data from Menet, Pfizer’s sunitinib malate capsules achieved global sales of $1.049 billion in 2018. Currently, Chia Tai Tianqing, CSPC Ouyi Pharmaceutical, Hansoh Pharmaceutical, and Qilu Pharmaceutical are competing to become the first generic manufacturer in the Chinese market.

Figure 1: Global Sales of Sunitinib Malate Capsules, 2013–2018 (Unit: Million USD)

(Source: Menet Database of Multinational Listed Companies' Sales)

Sunitinib is a small-molecule, multi-target receptor tyrosine kinase (RTK) inhibitor that exerts multiple effects, including inhibition of tumor angiogenesis and suppression of tumor cell proliferation and metastasis. Developed by Pfizer, the drug was first approved by the U.S. Food and Drug Administration (FDA) for marketing on January 26, 2006. According to the Menet Database of Sales from Multinational Listed Companies, the global sales revenue of Pfizer’s sunitinib malate capsules has declined year by year in recent years; nevertheless, it still achieved global sales of USD 1.049 billion in 2018.

Figure 2: Sales of Sunitinib Malate Capsules at Public Medical Institution Terminals in China, 2013–2018 (Unit: RMB 10,000)

(Source: Competitive Landscape of China's Public Medical Institutions Terminal from Menet Network)

Pfizer’s sunitinib malate capsules were approved by the National Medical Products Administration for entry into the Chinese market in 2007. In recent years, sales of this product at public healthcare institutions in China have fluctuated; in 2018, sales reached RMB 229 million, representing a year-on-year increase of 5.82%. Currently, only the original innovator product from Pfizer is available on the domestic market.

Table 1: Partial Generic Status of Sunitinib Malate Capsules

(Source: Menet MED China Drug Evaluation Database 2.0)

Multiple pharmaceutical companies in the Chinese market have already laid out their strategies for generic sunitinib malate capsules, with 17 generic drug marketing application acceptance numbers issued. Among them, 10 applications were submitted under the old Class 6 category and have all been approved for clinical trials; 7 applications are new Class 4 submissions, involving four pharmaceutical companies: Qilu Pharmaceutical, Chia Tai Tianqing Pharmaceutical, Hansoh Pharmaceutical, and CSPC Ouyi Pharmaceutical. Who will secure the first generic approval? Let us wait and see!

Original Title: [R&D] Pfizer’s $1 Billion Blockbuster Drug: CSPC, Chia Tai Tianqing, Qilu Pharmaceutical... Race for First Generic