Hansoh Pharma Set to Become Second Domestic Manufacturer to Launch Sunitinib Malate Capsules in China

Recently, the New Drug Application (NDA) under Category 4 for Hansoh Pharma’s Sunitinib Malate Capsules (Acceptance Number: CYHS1700651) has been updated to “Under Review.” The product is expected to be approved for marketing next month, making Hansoh Pharma the second pharmaceutical company, after CSPC Pharmaceutical Group, to obtain marketing authorization for this generic drug.

(Source: NMPA)

Billion-Dollar Global Anticancer Drug

Sunitinib Malate Capsules (Brand Name: Sutent) were developed by Pfizer and approved for marketing by the U.S. FDA in January 2006, followed by approval in the European Union in June of the same year. This drug 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. Its targets include PDGFR (PDGFRα and PDGFRβ), VEGFR (VEGFR1, VEGFR2, VEGFR3), FLT-3, CSF-1R, KIT, and RET. Clinically, it is primarily used for the treatment of adult patients with gastrointestinal stromal tumors, renal cell carcinoma, and pancreatic neuroendocrine tumors.

In the United States, sunitinib is a frequently prescribed oral medication approved for the treatment of advanced renal cell carcinoma. To date, more than 250,000 patients worldwide have received sunitinib therapy. However, in recent years, annual sales of sunitinib have gradually declined. According to global best-selling drug statistics, sunitinib surpassed the $1 billion sales threshold in 2010, with annual sales reaching $1.066 billion that year. Sales peaked in 2012 at $1.236 billion, after which they began to decline. In 2019, global sales amounted to $940 million, representing an 11% year-over-year decrease and marking the first time annual sales fell below the $1 billion mark.

In September 2007, sunitinib was approved by the National Medical Products Administration (NMPA) for marketing in China, available in capsule form with four strengths: 12.5 mg, 37.5 mg, 50 mg, and 25 mg. In the domestic market, although only Pfizer’s originator product was available prior to the approval of CSPC Pharmaceutical Group’s first generic version in January 2020, its market performance remained lukewarm. According to sales data from sample hospitals in China, the product’s annual sales between 2012 and 2018 exceeded RMB 50 million, yet it failed to rank among the country’s blockbuster drugs.

In 2018, sunitinib was included in the national medical insurance coverage following price negotiations. Currently, the national winning bid price for the 12.5 mg strength is RMB 155 per capsule, representing a nearly 65% decrease from the pre-negotiation winning bid price of approximately RMB 438.16 per capsule. Domestic sales revenue is expected to rise in the future.

CSPC Secures First Generic Approval

Sunitinib’s domestic compound patent in China is set to expire in 2021. According to the Insight database, CSPC Ouyi, Kelun, Qilu, Chia Tai Tianqing, and Hansoh Pharma have all submitted marketing applications for sunitinib under the New Drug Application Class 4.

(Source: Insight Database)

In January 2020, the Sunitinib Malate Capsules (12.5 mg) developed by CSPC Ouyi Pharmaceutical received the drug registration approval from the National Medical Products Administration (NMPA), becoming the first approved generic drug of this variety in China and deemed to have passed the consistency evaluation.

(Source: Company announcements)

It was initially expected that Chia Tai Tianqing would be the second company to secure approval for the generic drug, but it now appears that Hansoh Pharma has overtaken it.