In terms of its business model, Xinji Pharmaceuticals focuses on internally developing, clinically advancing, and ultimately commercializing improved new drugs based on its proprietary drug formulation platform technology.
Zhitong Finance APP has learned that, according to a disclosure by the Hong Kong Stock Exchange (HKEX) on July 24, Guangzhou Xinji Pharmaceuticals Co., Ltd. ("Xinji Pharmaceuticals") submitted an application for listing on the Main Board of HKEX, with Guotai Junan International acting as its sole sponsor. This marks the company’s second submission to HKEX, following an initial listing application filed on December 24, 2025.
Company Overview
According to the prospectus, Xinji Pharmaceuticals was founded in 2007 and is a clinical-stage pharmaceutical company. Building upon previously approved active pharmaceutical ingredients (APIs), the company leverages alternative formulations and drug delivery technologies to develop and commercialize improved new drugs.
Xinji Pharmaceuticals does not engage in the discovery or development of novel APIs. The company has independently developed two core products. Its lead product, dexmedetomidine hydrochloride microneedle patch (DHMP), is indicated for preoperative sedation in both pediatric and adult patients. The company initiated a Phase IIa clinical trial for the pediatric indication in China in August 2025 and completed the study in June 2026. Additionally, a Phase II clinical trial for the adult indication commenced in March 2026. The company’s second core product, XJN010, is an intranasal formulation designed for on-demand treatment of "off" episodes in Parkinson’s disease patients. A Phase II clinical trial for XJN010 began in China in August 2025 and was completed in April 2026. The company is also developing three additional pipeline candidates: XJN026 (for which a Phase I clinical trial commenced in April 2026), XJN1102, and XJN2503.
In terms of its business model, Xinji Pharmaceuticals focuses on internally researching, clinically advancing, and ultimately commercializing improved new drugs based on its proprietary formulation platform technologies. The company employs a structured evaluation process to identify, assess, and prioritize candidate products based on technical feasibility, competitive dynamics, and disease prevalence before advancing them into development. Leveraging its platform technologies, the company develops novel formulations designed to overcome limitations of conventional drug delivery routes and to enhance therapeutic efficacy, patient compliance, and clinical utility.
Concurrently, the company conducts regulatory planning and clinical development in accordance with requirements set forth by relevant regulatory authorities. Its commercialization strategy is supported by a robust manufacturing and supply framework, including non-commercial production facilities to support clinical-stage supply, while progressively establishing commercial-scale manufacturing facilities compliant with Good Manufacturing Practice (GMP) standards and engaging qualified contract manufacturing organizations (CMOs). Looking ahead, the company intends to advance product commercialization in China through a combination of internal market development and selective licensing or co-development arrangements for products with international potential.
As of the latest practicable date, none of Xinji Pharmaceuticals’ core or key products have received marketing approval. The company’s core products—including DHMP and XJN010—are currently undergoing clinical development. Since all pipeline products have been independently developed by the company, it holds global commercialization rights for these products.
Financial Information
Revenue
For the years ended December 31, 2024 and 2025, and for the five months ended May 31, 2025, the company generated revenue of approximately RMB 49.026 million, RMB 55.238 million, and RMB 16.567 million, respectively.
Gross Profit and Gross Margin
For the years ended December 31, 2024 and 2025, and for the five months ended May 31, 2025, the company recorded gross profit of approximately RMB 16.515 million, RMB 12.905 million, and RMB 3.278 million, representing gross margins of 33.7%, 23.4%, and 19.8%, respectively.
Total loss for the year and total comprehensive loss
For the years ended December 31, 2024 and 2025, and for the five months ended May 31, 2025, the company recorded total losses of approximately RMB 147 million, RMB 111 million, and RMB 197 million, respectively.
Industry Overview
The number of pediatric sedation patients in the United States is projected to increase modestly from 2.83 million in 2021 to an estimated 3.65 million by 2030, reflecting sustained demand. The market demonstrates steady growth momentum, with a compound annual growth rate (CAGR) of 2.65% from 2021 to 2025 and an estimated CAGR of 3.01% from 2026 to 2030. Globally, the total number of pediatric sedation patients is expected to rise slightly from 15.09 million to 15.69 million, with CAGRs of 0.29% and 0.46% for the respective periods. Overall, future market growth is anticipated to be primarily driven by the United States and China, while other regions exhibit a declining trend.
The number of adult sedation patients in the United States is expected to maintain steady growth, rising from 16.99 million in 2021 to an estimated 18.94 million by 2030. The market shows consistent expansion momentum, with a compound annual growth rate (CAGR) of 1.22% from 2021 to 2025 and an estimated CAGR of 1.21% from 2026 to 2030. Globally, the total number of adult sedation patients is projected to increase from 119.81 million to 131.68 million, with CAGRs of 0.94% from 2021 to 2025 and an estimated 1.13% from 2026 to 2030. Overall, the adult sedation market exhibits a stable upward trend throughout the forecast period.
China's preoperative sedation market is expanding steadily. In 2021, the overall market size reached approximately RMB 7.42 billion, comprising RMB 6.48 billion for adult sedatives and approximately RMB 940 million for pediatric sedatives. Benefiting from rising surgical volumes, growing demand for comfort-oriented medical services, and the broadening of approved indications for sedatives, the market size is projected to exceed RMB 7.76 billion by 2025, reach RMB 7.85 billion by 2026, and grow to approximately RMB 8.26 billion by 2030, representing a compound annual growth rate (CAGR) of approximately 1.26% from 2026 to 2030. The pediatric sedation segment is growing significantly faster than the adult segment, with an estimated CAGR of 2.57% from 2026 to 2030, serving as the primary driver of overall market expansion.
China's sedative market is expanding steadily. In 2021, the overall market size reached approximately RMB 7.42 billion, driven by gradually increasing surgical volumes and the widespread clinical adoption of sedation. By 2025, the market size is expected to grow to approximately RMB 7.76 billion. This upward trend is projected to continue, reaching an estimated RMB 7.85 billion in 2026 and approximately RMB 8.26 billion by 2030. In terms of growth rates, the compound annual growth rate (CAGR) is estimated at approximately 1.26% from 2026 to 2030, compared to 1.12% from 2021 to 2025. Overall, the market is expanding at a stable and gradual pace, reflecting moderate upward momentum even on a mature demand base.
China's pediatric sedation market has grown steadily from RMB 940 million in 2021 to RMB 1.02 billion in 2025, and is projected to further increase to RMB 1.15 billion by 2030. The market is expected to expand at a compound annual growth rate (CAGR) of 2.07% between 2021 and 2025, accelerating slightly to 2.57% between 2026 and 2030.
By segment, in 2025, the outpatient setting accounted for RMB 360 million, while the inpatient setting represented RMB 660 million, with the inpatient segment continuing to dominate the market.
Board of Directors Information
The Board currently comprises nine directors, including three executive directors, three non-executive directors, and three independent non-executive directors. The initial term of the Board is three years, during which it holds general authority to manage and operate the company’s business.
Equity Structure
As of the latest practicable date, Dr. Wu, the company’s founder, held approximately 23.15% of the shares and was deemed to hold an additional 22.43% through his role as general partner of several entities, including Baize Investment, Deji Investment, Shanjie Investment, and Guangji Investment. Dr. Wu and his spouse, Dr. Pan Xin, also held approximately 5.43% of the shares through Minji Investment, a company wholly owned by them. Consequently, Dr. Wu, Dr. Pan Xin, Baize Investment, Deji Investment, Shanjie Investment, Guangji Investment, and Minji Investment constitute the company’s controlling shareholder group, collectively holding approximately 51.01% of the shares as of the latest practicable date.
Other existing shareholders collectively hold 48.99% of the shares.
Intermediary Team
Sole Sponsor: Guotai Junan Financing Limited
Company Legal Counsel: Regarding Hong Kong law: Chen Qinren Law Firm; regarding U.S. law: TsingLaw NY LLP
Exclusive Sponsor's Legal Counsel: With respect to Hong Kong law: Johnson Chow & Co. in association with Tongshang Law Firm; with respect to PRC law: Han Kun Law Offices
Reporting Accountant and Auditor: Ernst & Young
Compliance Adviser: Guotai Junan Corporate Finance Limited
Industry Consultant: Frost & Sullivan (Beijing) Consulting Co., Ltd. Shanghai Branch
Intellectual Property Legal Counsel: Liu, Shen & Associates