Small-molecule drugs have significant potential in the current treatment of both oncological and non-oncological diseases. In recent years, with the expansion of medical insurance coverage, the continuous improvement of residents' affordability, and supportive policies that actively promote pharmaceutical innovation, the market for small-molecule drugs has been steadily growing. Meanwhile, an increasing number of pharmaceutical companies are accelerating their strategic investments in this promising field.
For instance, recently, Hansoh Pharmaceutical Group announced that its wholly-owned subsidiary, Hansoh (Shanghai) Health and Jiangsu Hansoh Pharmaceutical (collectively referred to as the Licensees), has entered into an exclusive licensing agreement with NiKang Therapeutics Inc.
The license agreement indicates that the licensee will be granted an exclusive license from NiKang Therapeutics to develop and commercialize NKT2152 for oncology treatment in China (including Hong Kong, Macau, and Taiwan). The licensee will pay an upfront fee of US$15 million, along with potential milestone payments totaling up to US$203 million for development, registration, and sales-based commercialization milestones. Additionally, a tiered royalty structure based on net sales will apply.
It is understood that NKT2152 is a small-molecule inhibitor of HIF-2α, currently undergoing a Phase I/II dose-escalation and expansion trial (NCT05119335). This trial aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical efficacy of the drug in patients with advanced clear-cell renal cell carcinoma (ccRCC).
Industry analysts believe that collaboration has increasingly become a strategic approach for many pharmaceutical companies entering the small-molecule drug sector. In recent years, announcements of collaborations in the small-molecule field have continued to emerge across the industry. For instance, on September 8 last year, Huadong Medicine announced the establishment of a partnership with Insilico Medicine to jointly accelerate the development of innovative small-molecule drugs targeting oncology. Under the agreement, Huadong Medicine and Insilico Medicine will collaborate closely through their respective research teams to initiate new drug discovery projects.
On August 31, Bichen Pharma, focusing on the development of small-molecule targeted drugs capable of crossing the blood-brain barrier, and Sansheng National Health jointly announced the signing of a strategic cooperation agreement. Under this agreement, both parties will leverage their respective technological and resource advantages to enhance collaboration in the development and exploration of new products and innovative technologies. Additionally, they will engage in extensive cooperation regarding the clinical development and regulatory submissions for innovative combination therapies targeting oncology drugs in the Chinese market.
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It is worth noting that, in addition to collaboration, many companies focused on small-molecule drug discovery are accelerating their fundraising efforts to expedite the development and commercialization of innovative research outcomes. For instance, on February 8 this year, Yousen Jianheng announced the successful completion of its Series A financing round, raising over 200 million yuan. This round was led by Shenzhen Fenxiang Investment, with participation from Zhangjiang HaoHeng and InnoVision Capital, while existing shareholders also continued to invest. According to reports, the funds raised in this round will be allocated toward advancing and expediting global clinical trials for UA007 and UA021, as well as driving the research and development of small-molecule drugs targeting multiple novel pathways and the development of highly specific bispecific antibody therapies.
On February 14, QinHao Pharma (Suzhou) Co., Ltd. (hereinafter referred to as "QinHao Pharma") also announced that the company has successfully completed a Series B financing round totaling several hundred million RMB. According to available information, QinHao Pharma is an innovative, globally-oriented biopharmaceutical company dedicated to the development of original small-molecule anti-cancer drugs. Currently, the company has established four comprehensive drug research and development centers: an Innovation Research Center, a Drug Design and Discovery Center, a New Drug Screening and Evaluation Center, and a Clinical Development Center. These centers have collectively formed a robust product pipeline comprising more than 10 ongoing projects.
Overall, as numerous pharmaceutical companies have entered the small-molecule drug sector and capital continues to pour into this space, the entire small-molecule drug market is poised for further growth. According to earlier data from Frost & Sullivan, China's small-molecule tumor-targeted therapy market has already expanded significantly—from 8.5 billion yuan in 2016 to 37.5 billion yuan in 2020. If current trends persist, the market is expected to reach 120.5 billion yuan by 2025 and further surge to 207 billion yuan by 2030. Against this backdrop, industry insiders anticipate that companies actively positioning themselves in this field will encounter even more opportunities for development.
Disclaimer: Under no circumstances should the information or opinions expressed in this document be construed as investment advice to anyone.
