Hepu Rui 2025 Annual Report Review: Building Industry Chain Competitiveness from Production Capacity to Platform

Ask AI · How can CDMO platforms and innovative drugs work together to drive an upgrade of the industrial chain?

China.com.cn Finance News, March 31—In global revenue growth, Enoxaparin Sodium injection formulation business achieved double-digit growth. Non-recurring profits and net profits increased by 66.11% year over year. Haisui (002399.SZ/09989.HK)’s 2025 financial report is impressive. Behind the increase in revenue scale and improvement in core profitability is an important turning point for Haisui: it has launched an industrialized manufacturing platform plus global commercial expansion. This domestic leading heparin-industry player is accelerating its push toward becoming a benchmark enterprise in global heparin—and even the pharmaceutical—industry.

The annual report shows that in 2025, on the operational side, Haisui steadily improved the company’s operational efficiency and core earning capability through more refined management. At the same time, represented by the Pingshan production base, the company made notable progress in three areas: quality certifications, intelligent manufacturing, and capacity expansion.

Specifically, Haisui’s newly built prefilled prefilled syringe (or prefilled) formulation production line at the Pingshan production base successfully obtained European GMP certification during the reporting period, as well as the EMA’s approval for adding Enoxaparin Sodium injection as an additional finished product manufacturer. This officially grants the company the “passport” for market access in the European Union. With quality certification qualifying it for access, the company’s total production capacity for Enoxaparin Sodium formulations also reached 550 million units, securing its scale advantage and maintaining its leading position in the industry.

As capacity is released, Haisui’s global commercialization capabilities are being upgraded in parallel. According to public information, Haisui currently relies on a localized operating system of subsidiaries in five European countries and the United States. It has already built an approved footprint covering more than 70 countries and regions and has achieved commercial sales in more than 50 countries.

In terms of intelligent manufacturing, it is also becoming an important lever for Haisui to build competitive barriers. It is understood that in the traditional model of the pharmaceutical industry, a company’s core competitiveness often manifests as the market performance of a single product or a cost advantage in a particular link. However, with increasingly strict global pharmaceutical regulation, continually rising supply-chain security requirements, and intensifying competition between innovative drugs and complex formulations, pharmaceutical intelligent manufacturing is becoming a key variable for companies to build systematic barriers.

Haisui’s annual report shows that during the reporting period, the company’s Pingshan 5G smart factory was successfully selected for the Ministry of Industry and Information Technology’s 《2025 5G Factory Directory》, becoming one of only 14 shortlisted enterprises in the national pharmaceutical manufacturing industry. This factory achieves end-to-end visualization and automation across production, quality, logistics, and energy. Product transport is carried out by automated AGV vehicles. Pharmaceutical production data is supported by a localized deployment to enable closed-loop flow, fully meeting the requirements for audits of U.S./European GMP and data integrity.

Even more worth noting is that this factory was also selected for the ISPE 2026 Facilities Award (FOYA), becoming the only Chinese enterprise on the current list—this also indicates that Haisui has reached international top-tier levels in pharmaceutical engineering, quality compliance, and global operations.

Meanwhile, beyond its heparin core business, Haisui, through its two major CDMO platforms, Saiwan Bio and SPL, precisely matches the R&D and production needs of global biopharmaceutical companies. With the coordinated operation of the two platforms, it demonstrates good business quality. At the same time, the company’s independently developed innovative candidate drug H1710 obtained approval from the National Medical Products Administration (NMPA) for a new drug clinical trial application (IND) in February 2025, and completed its first dosing in Phase Ia clinical research in July. The study plans to be conducted at three research centers, with an expected enrollment of about 36 patients with late-stage solid tumors.

From continuous breakthroughs—starting with leading capacity scale and extending through sustained progress in global market access—to global recognition of the 5G smart factory—Haisui is moving into a new stage of higher-quality development, leveraging systemic advantages spanning the entire industrial chain, thereby unlocking a broader space for performance growth imagination.