Anteng Ruilin Files IPO Prospectus: 24,000-Liter Total Capacity Accelerates Global Biologics Pipeline

Since 2022, the capital winter has gradually spread to every corner of the innovative drug industry chain, and the CDMO sector, which occupies a critical link between drug R&D and commercial sales, has not been spared. In order to survive, some CDMO companies have begun to adopt measures such as closing plants, laying off employees, engaging in price wars, and scaling down operations.

This year, the CDMO industry has been rife with challenges, yet opportunities have emerged amid these perils. At this critical juncture, some companies have still managed to seize opportunities through their strengths and break out from the increasingly cutthroat “red ocean” of the CDMO market.

ATON (Shanghai) Biotechnology Co., Ltd. (hereinafter referred to as “ATON”) is a biological CDMO enterprise that was born during the capital winter and has developed against the trend.。

Aton is a wholly-owned subsidiary of Shanghai Henlius Biotech, Inc. (“Henlius”), dedicated to quality-driven integrated biopharmaceutical development and manufacturing, empowering customers in the research, development, and production of new drugs.The company’s business scope covers end-to-end CDMO services, ranging from cell line development to commercial manufacturing, including the development and production of therapeutic modalities such as monoclonal antibodies, fusion proteins, bispecific antibodies, and antibody-drug conjugates (ADCs).。

In recent years, as the incidence rates of numerous diseases have risen, the market gap in demand for innovative drugs and novel therapeutic approaches has widened. Meanwhile, increased policy reforms and incentives supporting pharmaceutical innovation in China have fostered the emergence and development of domestically developed innovative drugs. According to the Annual Statistical Data on Drug Supervision and Administration (2022) released by the National Medical Products Administration (NMPA), the NMPA approved 1,615 clinical trial applications for innovative drugs in 2022, representing a year-on-year increase of 6.11%.

As is well known, new drug development is a high-risk, long-cycle, and costly process with slim odds of success; only about 10% of new drug candidates are approved to enter clinical trials. In terms of cost, according to statistics from Chemical Weekly, production costs account for approximately 30% of the total cost of new drug development, while outsourcing production to low-cost regions can reduce these costs by 40%–60%.

Therefore, CDMOs, with their dual advantages in customized R&D and manufacturing capabilities, have become a critical choice for pharmaceutical companies to enhance R&D efficiency, reduce R&D costs, and maximize the efficiency of commercialization.

Amid the explosive growth in domestic CDMO demand, ATON was established to meet the moment. “Following market research and evaluation, Shanghai Henlius Biotech, Inc. decided to establish a CDMO company capable of serving global biopharmaceutical enterprises, leveraging its existing capacity and strengths to provide customers with one-stop solutions and accelerate the R&D and market launch of new drugs,” said Dr. Gong Wei, General Manager of CMC Operations at ATON and a participant in the Fosun Star Future Entrepreneurship Camp.

Since its establishment over a year ago, ATON has built an internationally competitive team for biomedical R&D, manufacturing, and operational management, supported by a robust talent pipeline and well-defined organizational structure. The core management team brings an average of more than 15 years of senior management and industry experience from leading multinational pharmaceutical companies, spanning drug R&D, clinical development, manufacturing, CMC, quality, and compliance.

Dr. Gong Wei currently has over 17 years of experience in the biopharmaceutical industry, having held key positions at Novo Nordisk’s China R&D Center and Shanghai Henlius Biotech, Inc. During his tenure, he led the development and manufacturing of multiple fusion proteins, monoclonal antibody drugs, and antibody-drug conjugates (ADCs), overseeing process development, pilot-scale production, technology transfer, process characterization, process validation, and regulatory submissions for market approval across the entire spectrum from preclinical stages to commercialization.

Leveraging Henlius’s CMC platform expertise, global quality system, and GMP manufacturing capabilities, ATON currently operates two integrated R&D and production bases covering monoclonal antibodies, bispecific antibodies, fusion proteins, ADCs, and other modalities, with a future commercial production capacity of up to 24,000 liters. Furthermore, the quality management systems at these facilities comply with the requirements of the National Medical Products Administration (NMPA), the European Medicines Agency (EMA), and the U.S. Food and Drug Administration (FDA).

ATON’s two R&D and production bases can support antibody drug substance manufacturing at scales of 200 L, 500 L, and 2,000 L. Its formulation capabilities include liquid filling and lyophilization, with specifications ranging from 2R to 50R. ATON also operates China’s first pilot-scale workshop for end-to-end continuous flow manufacturing of drug substances, enabling fully continuous end-to-end production.

In addition, the company’s team has accumulated extensive project experience. To date,The team has filed over 70 INDs globally, developed and constructed more than 50 molecules, and manufactured over 140 clinical batches and 750 commercial batches., adhering to the fundamental principle of “quality first,” providing customers with comprehensive, one-stop solutions ranging from early preclinical development to commercial manufacturing. The scope of services includesCell line development and cell bank establishment; process development and purification process development for monoclonal antibodies, bispecific antibodies, fusion proteins, and ADC products; toxicology and clinical sample preparation; as well as process characterization and process validation.。

Notably, ATON possesses robust CMC development and manufacturing capabilities for ADC products. The company’s ADC platform encompasses a variety of conjugation technologies, supporting multiple conjugation sites including lysine (random) and interchain disulfide bonds (random/directed). Furthermore, it supports conjugated drug substance production at scales up to 500 grams per batch, along with OEB-5 isolator-based aseptic filling and lyophilization lines, offering a lyophilization capacity of over 6,000 vials per batch. ATON provides comprehensive ADC analytical method development and testing services, meeting diverse dosage requirements from small-scale trials through clinical stages.

Meanwhile,ATON Prioritizes Customer Information IP and Intellectual Property Protection, strictly adhering to the six core principles of “approval-controlled processes, prevention-first approach, work-related relevance, customer requirements, least privilege access, and prioritized focus,” upholding a service ethos of “honesty and integrity,” and establishing an intellectual property protection policy to safeguard customer interests.

In November 2023, ATON announced the launch of the ATONEST analytical testing service platform to meet customer demands for biotherapeutic analysis and testing, thereby facilitating the regulatory approval and successful market launch of various analytical tests required for new drug development.

The services provided by the ATONEST platform cover seven major analytical and testing sectors, namely: R&D and characterization testing; stability testing and storage; in-process control and release testing for antibodies and ADCs; microbial, environmental, and water system testing; bioactivity testing; raw material and packaging material testing; and elemental impurities analysis (ICH Q3D).The platform currently offers over 180 analytical testing services, including 46 assays for in-process control and release testing of antibodies and ADCs, 45 tests for raw materials, excipients, and packaging materials, and 35 assays related to R&D and characterization.On this basis, ATON can provide reliable and effective professional testing report support for the research, development, and market launch of new drugs.

Empowered by the ATONEST platform, Aton Biologics has expanded its service scope to offer one-stop CTDMO services, covering cell line construction, analytical method development and validation, process development, IND filing, clinical sample manufacturing, global marketing authorization applications, as well as commercial-scale production and testing. This enhancement enables the company to provide more comprehensive new drug R&D services and better meet diverse market demands.

Leveraging its technology R&D platform and team, ATON has successfully provided clients with one-stop CMC services, including process development, analytical method development, clinical sample manufacturing, and IND application support, thereby helping their investigational new drugs secure FDA IND approval. In addition, the company has secured multiple collaborative orders with clients, further accelerating their new drug R&D processes.

As of December 2023, ATON has established a service platform system meeting international standards, with the capability to independently handle orders for various types of molecules. It has successfully supported clients in securing their first FDA IND approval, and achieved milestones including its first international order, first ADC project order, first late-stage clinical trial order, and first radiopharmaceutical project order, earning high acclaim from customers.

Currently, despite the chill of the capital winter reaching the CDMO industry and intense market competition, ATON continues to advance steadily within the sector. By leveraging its comprehensive services and stable delivery capabilities, the company has accumulated a strong client base and positive reputation, while continuously securing new collaborative projects.

Dr. Gong Wei stated, “For a company to survive, beyond production capacity and technology, the most critical factor is possessing ‘integrity’ credentials and earning long-term trust from customers.” Facing the pressures of stringent regulation and competition from both domestic and international rivals, ATON has not only built a moat around its patented technologies and service quality but also emphasized the gradual accumulation of qualifications and mutual trust with clients, thereby continuously strengthening its competitive moat and refining its differentiated advantages.

According to the “Research Report on the Current Status and Future Trends of the CDMO Industry” released by Frost & Sullivan, the CDMO industry is growing in tandem with the positive development of China’s innovative drug sector. The market size of China’s CDMO industry increased from RMB 13.2 billion in 2017 to RMB 47.3 billion in 2021, and is projected to reach RMB 157.1 billion by 2025, accounting for more than one-fifth of the global market share thereafter. Despite facing significant challenges, the CDMO industry’s future prospects remain promising.

Looking ahead, ATON will build on its established track record to further empower the commercialization process in the Chinese market, refine high-quality management and sustainable development practices, and accelerate the construction of an integrated comprehensive production platform. Furthermore, the company will leverage its existing advantages to enhance competitiveness, expedite its expansion into overseas markets, provide global biopharmaceutical companies with personalized, one-stop solutions covering the entire drug lifecycle, improve access to high-quality biologics, and navigate the intense currents of market competition.

Fosun Star Future Institute, established by Fosun Group in partnership with Fosun Pharma, integrates industrial resources across Fosun’s biopharmaceuticals, medical devices and diagnostics, healthcare services, health insurance, and elderly care sectors. It serves as a platform for entrepreneurs and business leaders in the medical and broader healthcare industries, operating under an “investment + mentorship + incubation” model. The institute features instruction from industry luminaries, provides direct access to Fosun’s various business units and supply chains, and is backed by substantial industrial capital from numerous Fosun-affiliated funds and strategic business development initiatives, thereby enabling early identification and investment in future unicorns.

Fosun Future Health Entrepreneurship Camp (Phase 5) Is Now Actively Recruiting!