China's First Dual-Chamber Lyophilized Drug Production Line Launched in Chengdu: VISEN Pharmaceuticals and WuXi Biologics Fill Domestic Technology Gap

VCBeat has learned that on June 9, 2025, at the launch event for WuXi Biologics’ commercial microbial production facility in Chengdu, VISEN (2561.HK), an innovative biopharmaceutical company focused on endocrine-related therapeutic areas, and WuXi Biologics (2269.HK) announced a significant milestone in their collaboration:VISEN’s Technology Transfer Project for Commercial Batches of Its Core Product, Lonapegsomatropin, Officially Lands in Chengdu

In addition, both parties will also be based at this facilityJointly build China's first dual-chamber lyophilized formulation production line,This innovative pharmaceutical formulation production technology can significantly enhance drug stability and ease of use.

Notably, VISEN and WuXi Biologics first established a strategic partnership for the technology transfer of lonapegsomatropin in December 2023. This upgraded collaboration marks further implementation of localized production for lonapegsomatropin, as both parties smoothly advance toward the next milestone.

China is currently the world’s largest market for growth hormone, characterized by low penetration and rapid growth. According to Frost & Sullivan, the number of pediatric patients with growth hormone deficiency (PGHD) in China reached 3.3746 million in 2022. VISEN Pharmaceuticals’ long-acting somatropin, a novel long-acting growth hormone indicated for the treatment of pediatric growth hormone deficiency, is poised to offer new therapeutic options for many affected children. The product has already been approved for marketing in the United States and Europe. It is expected to receive regulatory approval in China in 2025, launch in the following year, and achieve localized commercial production by 2028.

Lonapegsomatropin is a new generation of long-acting growth hormone developed based on the “TransCon (Transient Conjugation)” technology platform,It provides a slow and sustained release of the unmodified prototype drug, which is identical to natural human growth hormone, offering a more physiological and steady growth hormone release profile. This not only reduces the frequency of injections, significantly improving patient compliance and treatment experience to achieve long-acting therapeutic goals, but also maintains good safety and tolerability.Technological innovations in the mechanism of drug action will bring better therapeutic outcomes for patients. The results of two Phase III clinical trials of long-acting somatropin, conducted both domestically and internationally, have both met the primary endpoints demonstrating superiority over the daily formulation.

Furthermore, unlike other growth hormone products that must be stored at 2–8°C (refrigerated), Longpei somatropin can be stored at room temperature for six months without refrigeration, which significantly enhances the convenience of carrying and use for patients.

“Lonapegsomatropin’s performance in the European and U.S. markets has already validated its clinical value,” said Lu Anbang, CEO of VISEN Pharmaceuticals. “However, local manufacturing is a crucial step to ensuring that Chinese patients truly benefit.”

This technology transfer implementation faces three major challenges:First, the product’s quality management system must simultaneously meet the triple quality certification requirements of the FDA, EMA, and NMPA. Second, the TransCon technology platform is highly complex, with only a handful of CDMOs in China possessing the capability to undertake such projects. Most importantly, the imported long-acting growth hormone product utilizes a dual-chamber delivery device; locally manufactured products will inherit this design. While this technology significantly enhances patient convenience and safety, it remains an unmet need in the domestic market.

Dual-chamber technology involves storing lyophilized drugs and reconstitution solvents separately in two independent chambers within a sealed container system, thereby maintaining the independent stability of both components during storage. Prior to injection, the lyophilized drug is reconstituted with the solvent via a bypass channel, which significantly enhances the convenience, safety, and dosing accuracy of drug administration. Due to its ease of use, this system enables patients to self-administer medication. For active ingredients in sensitive biological macromolecule drugs (such as peptides and vaccines), the dual-chamber sealed system allows mixing or reconstitution of the two contents only immediately before administration, helping to maintain the shelf-life stability of the active ingredients and reducing degradation or inactivation caused by prolonged contact. For medications requiring long-term, frequent injections, such as those for chronic diseases, dual-chamber technology eliminates the complex steps of drawing, reconstituting, and redrawing associated with traditional syringes. This significantly reduces operational difficulty and the risk of errors. Furthermore, the closed dual-chamber system minimizes the risk of introducing microbial or particulate contamination during multiple aspiration procedures, thereby greatly improving the feasibility of home-based self-administration and patient treatment adherence.

VISEN Pharmaceuticals has always adhered to a patient-centric approach. In selecting the formulation and delivery device for the locally produced long-acting recombinant human growth hormone, the CMC team independently developed and optimized the design of a domestically manufactured dual-chamber delivery device. This was done to maintain the same level of convenience, compliance, and safety as imported products. The aim is to introduce advanced drug delivery technology paired with a novel long-acting growth hormone, filling the domestic gap in this field and better serving Chinese patients.

Despite the significant challenges in designing and implementing a dual-chamber lyophilized formulation production line, VISEN is steadily overcoming these technical hurdles by leveraging its proprietary patent advantages in dual-chamber technology, in collaboration with WuXi Biologics’ advanced process development system and cGMP quality management standards.

Dr. Chen Zhisheng, CEO of WuXi Biologics, stated, “The successful commercial launch of the lonapegsomatropin project as the ‘first order’ from our microbial commercial production base in Chengdu is a strong endorsement of our microbial technology platform and commercial manufacturing capabilities. Leveraging our globally leading process development system and cGMP quality management standards, we will provide VISEN with an end-to-end solution spanning from technology transfer to large-scale production.”

With the commissioning of China’s first dual-chamber lyophilized formulation production line, WuXi Biologics will also take the lead in establishing manufacturing technologies for dual-chamber lyophilized formulations. It is understood that WuXi Biologics is one of the few CRDMO companies globally equipped with an end-to-end integrated microbial fermentation technology platform. The launch of this production line will further strengthen WuXi Biologics’ capabilities in formulation manufacturing technology.

WuXi Biologics’ Microbiology Platform supports process development and scale-up manufacturing for various dosage forms, including liquid formulations, lyophilized formulations, pre-filled syringes, and dual-chamber formulations.

“WuXi Biologics has established a team dedicated to the development of lyophilization technologies, successfully developing over 100 lyophilization formulations and processes covering various types of molecules. All have entered either the Investigational New Drug (IND) stage or commercial production. The company has also successfully built a digital platform for lyophilization process scale-up and technology transfer, balancing production costs with technology transfer efficiency.”Dr. Chen Zhisheng pointed out.

WuXi Biologics has established microbial drug R&D and GMP manufacturing capabilities in Shanghai and Hangzhou,The commercial-scale microbial production base in Chengdu represents another major strategic expansion following those in Shanghai and Hangzhou, further enhancing its end-to-end development capabilities for microbial drugs from concept to commercial manufacturing.VCBeat has learned that the initial phase of WuXi Biologics’ Chengdu facility will be equipped with 15,000-liter bioreactors, with an annual bulk drug substance production capacity of 80–110 batches. The fermentation scale is expandable to 60,000 liters in the future. The site is also building a dual-chamber formulation production line and a vial filling line, with a total annual output exceeding 10 million units.

One of the challenges in implementing a dual-chamber lyophilized formulation production line is ensuring that the drug quality at the Chengdu manufacturing site remains consistent with that of the originator site.

A robust quality management system is one of WuXi Biologics’ core competitive advantages. Currently, WuXi Biologics has established a global network comprising four research centers, eight development centers, and eight manufacturing facilities, implementing “globally unified quality standards.” As of the end of 2024, WuXi Biologics had successfully undergone 42 inspections by 12 regulatory authorities worldwide, including the U.S. FDA, the European EMA, and China’s NMPA.

Taking WuXi Biologics’ microbiology team as an example, its end-to-end isolation design—with independent zones for strain development, production, and quality control—combined with a high-throughput screening platform and an intelligent temperature control system, mitigates the risks of cross-contamination and process variability at the source. Furthermore, its professional QC team provides full-chain services, including analytical method transfer, cell bank testing, and raw and auxiliary material quality control, ensuring that every batch of products meets the highest international standards.

In terms of R&D efficiency, WuXi Biologics has successfully leveraged technologies such as mass spectrometry and metabolic engineering to develop its proprietary Effix™ E. coli cell line platform. This platform provides high-yielding, high-quality, safe, and stable cell lines for drug molecule process development and GMP manufacturing, with target protein titers exceeding 15 g/L.

In addition to a suite of innovative technology platforms, WuXi Biologics demonstrates advantages in project execution efficiency that far exceed the industry average. Taking WuXi Biologics’ integrated microbial platform capabilities as an example, the company leverages the technical prowess behind “WuXi Biologics Speed” to significantly compress R&D and production cycles—

6 months: Complete full CMC deliverables from plasmid DNA to IND filing;

2-3 weeks: Rapidly generate and deliver R&D materials;

2 months: Conduct a feasibility study on the process from gene sequencing to PCB (cell bank construction);

4 months: Complete the development and production of non-GMP products, such as enzymatic tools.

“We evaluated major CDMO companies in China and ultimately chose WuXi Biologics, precisely because of its globally leading technological capabilities and quality systems,” emphasized Lu Anbang.

It is precisely this “rapid response” capability that provides strong support for VISEN to seize the first-mover advantage in the market with its first commercialized product.

“Localized production brings not only cost advantages but also enhanced supply chain security,” pointed out Lu Anbang. Through WuXi Biologics’ large-scale manufacturing capabilities, the production cost of lonapegsomatropin is expected to be significantly reduced; for patients, localized production means more accessible treatment options, thereby improving drug accessibility.

On April 23, 2024, the National Medical Products Administration (NMPA) issued the "Announcement on Optimizing Matters Related to Marketing Authorization Applications for Transferring the Production of Overseas-Manufactured Drugs Already Marketed in China to Domestic Production." The Center for Drug Evaluation (CDE) under the NMPA subsequently released the "Notice on Requirements for Submission Materials for Marketing Authorization Applications for Transferring the Production of Marketed Overseas-Manufactured Drugs to Domestic Production (Therapeutic Biological Products)."

The localized production of long-acting growth hormone is a typical example of innovative drugs developed under such national incentive policies. It is evident that China is implementing a series of measures to optimize the business and investment environment for both domestic and foreign pharmaceutical companies, promote high-quality development of the pharmaceutical industry, enhance drug accessibility, and advance the internationalization of drug regulation.

Subsequently, the long-acting growth hormone project will become the “first” commercialized outcome at Chengdu’s microbial commercial production base. Leveraging its globally leading process development system and cGMP quality management standards, WuXi Biologics has created a full-chain solution for VISEN, spanning from technology transfer to commercial manufacturing. This successful experience not only ensures the localized production of the long-acting growth hormone but also provides a replicable model for WuXi Biologics’ collaborations on other projects.

Looking back on its development trajectory, it is noteworthy that VISEN has adopted a “two-step” strategy: meeting immediate demand through imports while simultaneously advancing localized production to safeguard long-term supply. Currently, the company has signed an agreement with an international supplier under Shanghai Pharmaceuticals Holding Co., Ltd. to ensure timely product availability following regulatory approval.

The successful implementation of this collaboration not only signifies a successful technology transfer,It also represents an exploration of the industrialization model for innovative drugs in China, carrying multiple strategic implications:On one hand, it fills the technological gap in China’s dual-lumen delivery system sector, setting a new technical benchmark for the industry; on the other hand, by leveraging efficient and professional local capabilities, it has successfully developed dual-lumen technology with independent intellectual property rights. This achievement not only realizes the localization of core technologies but also provides an advanced delivery solution that can serve as a reference for other domestic biopharmaceutical products.

Meanwhile, this deep collaboration model between biotech firms and CXOs is creating a win-win situation: WuXi Biologics supports the development of advanced manufacturing technologies, VISEN accelerates product commercialization, and patients gain earlier access to innovative treatment options. As Lu Anbang stated, “We hope this partnership will attract more global innovative pharmaceutical companies to focus on the Chinese market, jointly elevating the standard of endocrine disease treatment in China.”

With the commissioning of the Chengdu facility, China’s biopharmaceutical industry will gain a production base with international competitiveness. The localized production of Lonapegsomatropin will also serve as a microcosm of the enhanced industrialization capabilities for innovative drugs in China. In the future, this collaborative model may become the standard paradigm for the local production of innovative drugs, driving the upgrading and transformation of the entire industrial ecosystem.