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Chongqing Liyang Pharmaceutical Development Co., Ltd.

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The market for small-molecule targeted drugs is experiencing rapid growth and is expected to reach 100 billion yuan by 2025.

Small-molecule drugs currently hold significant potential in the treatment of both oncological and non-oncological diseases. In recent years, with the expansion of medical insurance coverage, the growing affordability of residents, and supportive policies aimed at fostering pharmaceutical innovation, the market for small-molecule drugs has continued to expand. As a result, an increasing number of pharmaceutical companies have accelerated their strategic investments in this promising field. For instance, recently, Hansoh Pharmaceutical Group announced that its wholly-owned subsidiary, Hansoh (Shanghai) Health, together with Jiangsu Haosen Pharmaceutical (collectively referred to as the Licensee), has entered into an exclusive licensing agreement with NiKang Therapeutics Inc. According to the agreement, the Licensee will receive an exclusive license from NiKang Therapeutics to develop and commercialize NKT2152 for the treatment of cancer in China, including Hong Kong, Macau, and Taiwan. The Licensee is required to pay an upfront fee of US$15 million, along with milestone payments totaling up to US$203 million contingent upon development, regulatory approval, and sales-based commercialization achievements, as well as tiered royalties based on net sales. It is worth noting that NKT2152 is a small-molecule inhibitor targeting HIF-2α, currently undergoing Phase I/II dose-escalation and expansion trials (NCT05119335). These trials are designed 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 suggest that collaboration has become a common strategy among pharmaceutical companies seeking to establish a foothold in the small-molecule drug arena. Over the past few years, there has been a steady stream of announcements regarding partnerships within the industry focused on small-molecule therapies. For example, on September 8 last year, Huadong Medicine announced a collaborative partnership with Insilico Medicine to jointly accelerate the development of innovative small-molecule drugs in the oncology space. Under the terms of the agreement, Huadong Medicine and Insilico Medicine will launch new drug discovery projects through close collaboration between their respective research teams. On August 31, BiChen Pharma, a company specializing in the development of small-molecule targeted drugs capable of crossing the blood-brain barrier, announced a strategic collaboration with Sansheng National Health. Under the agreement, both parties will leverage their respective technological and resource advantages to strengthen joint efforts in developing new products and technologies. Additionally, they will collaborate extensively on the clinical development and regulatory submissions for innovative combination therapies targeting oncological indications in the Chinese market. Notably, beyond collaboration, many companies dedicated to the research and development of novel small-molecule drugs are also accelerating their fundraising activities to expedite the translation of scientific breakthroughs into tangible therapeutic advancements. For instance, on February 8 this year, Yousen Jianheng announced the successful completion of a Series A financing round exceeding RMB 200 million. This round was led by Shenzhen Fenxiang Investment, with participation from Zhangjiang HaoHeng and Yingke Capital, while existing shareholders also continued to invest. The funds raised will be utilized to advance global clinical trials for UA007 and UA021, as well as to accelerate the development of multiple small-molecule drugs targeting novel targets and innovative bispecific antibody therapies. Similarly, on February 14, Qinhao Pharma (Suzhou) Co., Ltd. (hereinafter referred to as "Qinhao Pharma") announced the successful closing of a Series B financing round valued at several hundred million RMB. Qinhao Pharma is described as a globally oriented, innovative biopharmaceutical company focused on the development of original small-molecule anti-cancer drugs. The company has already established four comprehensive drug R&D centers—covering innovative research, drug design and discovery, drug screening and evaluation, and clinical development—and has built a robust product pipeline comprising more than ten ongoing projects. Overall, as numerous pharmaceutical companies increasingly enter the small-molecule drug sector and capital continues to flow into the space, the entire market is poised for further growth and development. Earlier data from Frost & Sullivan indicated that China’s small-molecule tumor-targeted therapy market grew from RMB 8.5 billion in 2016 to RMB 37.5 billion in 2020. If current trends persist, the market is projected to reach RMB 120.5 billion by 2025 and further expand to RMB 207 billion by 2030. Against this backdrop, industry experts anticipate that companies actively engaged in this field will encounter enhanced opportunities for growth and success. **Disclaimer:** The information or opinions expressed in this article do not constitute investment advice to any individual under any circumstances.

2022

05-06

Leveraging AI to accelerate the development of innovative therapies has become a consensus among pharmaceutical companies both domestically and internationally.

Recently, Genesis Therapeutics announced a collaboration with Eli Lilly and Company to leverage Genesis's AI-driven drug discovery platform in identifying innovative therapies targeting up to five distinct targets across multiple therapeutic areas. Under the agreement, scientists from both Genesis and Eli Lilly will jointly utilize Genesis's AI platform to develop potential "first-in-class" and "best-in-class" drug candidates for three of these targets.

2022

05-06

The pharmaceutical industry is embracing a "cross-industry" trend, with the greater health sector emerging as a key focus for strategic expansion.

As aging populations intensify and consumer preferences continue to evolve, the greater health industry is demonstrating robust growth momentum. According to incomplete statistics, the market size of the greater health industry reached 7 trillion yuan in 2020 alone. At this rate, industry forecasts suggest that the market could surpass 8 trillion yuan by 2022. Against the backdrop of the booming greater health sector, the concept of "health" continues to gain significant traction, prompting an increasing number of pharmaceutical companies to embrace the "health" narrative and explore cross-industry opportunities to break away from their traditionally single-product business models. Notably, on April 19, Huahai Pharmaceutical officially established Zhejiang Freeze-Dried Idealism Technology Co., Ltd., with a registered capital of 10 million yuan. This new entity is a wholly-owned subsidiary of Huahai Pharmaceutical.

2022

05-06

The pace of domestically innovative drugs gaining market approval will continue to accelerate, unleashing greater new vitality.

According to the 2021 annual report released by the pharmaceutical company, segments such as vaccines, medical devices, and healthcare services delivered impressive performance, while the pace of innovative drug approvals continued to accelerate. Additionally, several innovative pharmaceutical companies previously operating at a loss have seen their losses narrow or even turn profitable, thanks to the launch of blockbuster products. For instance, Junshi Biosciences experienced significant growth in revenue, increasing by 152.36% year-on-year, primarily driven by substantial gains from technology licensing income, newly added royalty revenues, and sales proceeds generated from the commercialization of toripalimab injection in the domestic market. Financial data indicates that Junshi Biosciences achieved an operating revenue of 4.025 billion yuan in 2021.

2022

05-06

Two Departments Issue Document: Improving Supporting Measures for National Insulin Volume-Based Procurement and Usage

On April 29, the National Healthcare Security Administration and the National Health Commission jointly issued the "Notice on Improving Supporting Measures for the National Centralized Bulk Procurement and Use of Drugs (Insulin Special)" (hereinafter referred to as the "Notice"). The Notice clearly states that medical institutions shall prioritize the use of selected insulin products, provided that medical quality and safety are ensured. The Notice further indicates that the insulin products selected through centralized procurement will be listed on provincial-level pharmaceutical centralized procurement platforms at their winning prices, leveraging the national unified medical insurance information platform's drug and medical consumables procurement management subsystem. Specifically, pre-filled, special-concentration, and long-acting insulin products will be priced per vial based on the winning price of the corresponding cartridge-type insulin products from the same manufacturer and product category.

2022

05-06

April's Major Pharmaceutical Events: Policy Highlights—Focusing on DRG Reform and Traditional Chinese Medicine, among Other Areas

In April, the National Healthcare Security Administration, the National Medical Products Administration, and other departments released several new policies and regulations related to the pharmaceutical industry, covering areas such as DRG reform, pharmacovigilance inspections, and traditional Chinese medicine. The author has provided a brief overview of these developments, intended solely for industry reference. The National Healthcare Security Administration Issues New Notice on DRG Reform On April 15, 2022, the National Healthcare Security Administration issued the "Notice on Coordinating the Implementation of DRG/DIP Functional Modules in the Payment Method Management Subsystem" (hereinafter referred to as the "Notice"). According to the timeline outlined, starting from April 2022, selected provincial-level medical insurance information platforms will undergo testing to ensure smooth integration with DRG/DIP-related functionalities.

2022

05-06

This year, various regions are accelerating efforts to promote high-quality development of the biopharmaceutical industry!

The biopharmaceutical industry refers to the collective economic entities that apply research achievements from biotechnologies such as genetic engineering, cell engineering, enzyme engineering, fermentation engineering, and protein engineering to the pharmaceutical sector, enabling the production and large-scale manufacturing of marketable drugs. In recent years, driven by a series of domestic policies aimed at promoting biopharmaceutical development, China's biopharmaceutical industry has accelerated its innovation-driven growth, with the market size steadily expanding. Amidst the positive momentum in the biopharmaceutical industry, various regions across the country are now further stepping up efforts to foster high-quality industrial development. Notably, several localities have already successively unveiled their respective plans for advancing the biopharmaceutical industry this year.

2022

05-06

Key alliance procurement initiatives planned for 2022 have been clearly defined!

The centralized procurement policy is closely tied to the hearts of everyone in the pharmaceutical industry. Recently, the National Healthcare Security Administration has issued unified deployment and coordination for local alliance-based centralized procurement initiatives, making it a key area of focus. The Administration clearly stated that by the end of 2022, each province (including inter-provincial alliances) should have procured no fewer than 100 drug varieties, covering chemical medicines, traditional Chinese medicine preparations, as well as consumables such as orthopedic trauma products, dental implants, and drug-eluting balloons. For key product categories, provinces will be designated as leading entities based on their respective intentions and capabilities, while other interested provinces are encouraged to proactively join, thereby expanding the scope of the alliances and optimizing the frequency and pace of centralized procurement activities. In 2022, two major alliances are planned to be prioritized for advancement.

2022

05-06

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