Hisense's new drug makes a powerful debut, reigniting the 1 trillion yuan market wave

On March 13, Hisense announced two updates: the innovative drug HSK31679 tablets was successfully included in the Breakthrough Therapy Designation program, and the clinical applications for two indications of the innovative drug HSK44459 cream received approval. In recent years, Hisense has aggressively entered the 1 trillion yuan chemical drug market with its innovative drugs, and its Class 1 anesthetic remimazolam injection has grown into a blockbuster exceeding 1 billion yuan.

It is reported that the chemical drug Class 1 new drug HSK31679 tablets is an independently developed highly selective thyroid hormone β receptor (THR-β) agonist. The company obtained its first clinical approval in 2022 for treating adult primary hypercholesterolemia. In 2023, a new indication for non-alcoholic steatohepatitis (NASH) was approved for clinical trials. Data from Minet shows that both indications of this new drug are currently in Phase II clinical trials.

On March 12, HSK31679 tablets were officially included in the “Breakthrough Therapy List,” making it the first THR-β agonist in China to be designated as a breakthrough therapy. Currently, no drugs in China are approved for the treatment of NASH. The company’s announcement mentioned that after being included in the breakthrough therapy list, HSK31679 tablets is expected to receive priority review during the registration process, accelerating the drug’s market approval.

On March 13, according to the CDE official website, Hisense submitted a clinical application for the Class 1 chemical drug HSK44459 cream and received approval. The main indications are psoriasis and atopic dermatitis.

The announcement states that preclinical research shows HSK44459 cream has a clear target, proven efficacy, good safety, and is a highly promising small molecule drug. It offers a high benefit/risk ratio in clinical applications, with broad prospects for clinical use, and is expected to become an effective treatment for psoriasis and atopic dermatitis.

To date, Hisense has had four Class 1 new drugs approved, all chemical drugs. The anesthetic Class 1 drug remimazolam injection, approved in 2020, has achieved sales exceeding 1 billion yuan in China’s three major terminal markets and six major markets by 2024, reaching 1.28 billion yuan in Q1-Q3 2025. The approved painkiller Class 1 drug, phenylsulfonyl carbapenem capsules, saw a growth rate of 2,680.19% in Q1-Q3 2025. The Class 1 diabetes drug, sitagliptin tablets, grew by 839.16% in the same period.

Hisense’s Class 1 new drugs have gained high recognition after entering the market, with sales continuing to rise. In 2024, the market size for chemical drugs in China’s three major terminal markets (see end of article for scope) reached 1,037.6 billion yuan. In Q1-Q3 2025, Hisense ranked among the top 35 in the chemical drug market (Tier 1).

Statistics show that Hisense has applied for over 30 Class 1 chemical drugs. Besides the four already approved, HSK39297 tablets submitted their first marketing application in January 2026. This drug is a highly effective, selective complement factor B (FB) small molecule inhibitor. Among the drugs in clinical stages, HSK31858 tablets started Phase III trials in 2024. This drug is an oral, potent, highly selective dipeptidyl peptidase-1 (DPP1) small molecule inhibitor.