Guarding Patients and Innovation

In an era where globalization and protectionism coexist, the rapid iteration of cutting-edge technologies, along with multiple constraints from policies and capital, has posed unprecedented challenges for pharmaceutical innovation companies. They must tackle issues such as multinational regulation and high costs while also bearing the medical ethical responsibilities of the international community to ensure that patients can receive timely treatment.

For companies focused on cell and gene therapy (CGT), this pressure is even more pronounced: on one hand, there is the "unique treatment opportunity" brought by personalized therapies, and on the other hand, there are layers of regulations and industrial barriers.

In the past year, the topic of the "Biosafety Law" has been frequently mentioned in the political arenas of multiple countries, and the trends of related reviews and restrictions have attracted widespread attention. For large innovative drug research and development companies like WuXi AppTec, which have a high degree of internationalization and extensive layouts, this not only means additional challenges in an already complex business environment but also relates to the vital interests of countless patients and practitioners.

Recently, WuXi AppTec announced that it would sell its cell and gene therapy (CGT) business WuXi ATU's U.S. and U.K. operating entities to Altaris, a private equity fund focused on the healthcare industry in the United States. Once this move was disclosed, it sparked discussions within the industry: Is this related to the "Biosafety Law"? What considerations did the company undergo to make this decision?

The "Biosafety Law" in the Legislative Process: The Beginning of the Sale, but Not Necessarily the Fundamental Reason

The seemingly "lofty" initiative of the Biosafety Law actually conceals many industrial protection purposes and the struggles of interest groups. U.S. politician Rand Paul has publicly expressed doubts about the related legislation, accusing it of not genuinely safeguarding national security interests but rather creating an unfair competitive environment for specific interest groups, which he views as a narrow protectionist behavior.

This is indeed the case; for such legislation, slogans like "national defense" and "public safety" largely serve as interchangeable "cloaks," aimed at targeting specific entities that are difficult to defeat through market competition under equal conditions.

However, the damage is not limited to fairness. The process of drug development, from the laboratory to clinical trials and then to approval and market launch, typically takes several years. Manipulations achieved through slogans like "public safety" could potentially lead to missing the market window for the best possible therapies for a patient group.

While companies may lose their competitive opportunities, they can still adjust and retaliate in the market. Patients in specific disease stages, however, lose treatment options, and the harm they suffer is difficult to compensate for. Especially for highly personalized treatment options like CGT, which cannot be replicated or replaced, there is a greater need for "time" and "efficiency" to align for the benefit of patients.

WuXi AppTec has thrived on the need for collaboration in the global innovative drug industry. In the innovative drug sector, the existence of CXOs essentially represents an extreme division of labor in a global context. The company has been able to become a leading global pharmaceutical research and development and manufacturing service platform in just a few decades, precisely due to its excellent research and collaboration capabilities, earning the trust of global clients.

Now, standing in the spotlight as a primary target of the "Biosafety Law," WuXi AppTec indeed has to weigh the pros and cons from all sides, especially the actual needs of patients. For WuXi AppTec, the current decision is not an easy choice at all This sale is not merely aimed at reducing the risks associated with the biosafety bill. The current environment in which the company finds itself is clear and predictable. If risk reduction were the top priority, related asset divestitures and sales could have been initiated at the best timing mid-year, without waiting for the legislative process to advance further to the current stage before accelerating the process.

It is evident that behind this sale, in addition to the bill itself, WuXi AppTec has more considerations.

Special Situation of the CGT Industry - Weakening Financing and Intensified Global Regulation

The financing situation in the CGT sector has not been very optimistic in the past two years. According to analysis data from Jefferies in November, global biopharmaceutical financing increased by 43% year-on-year in 2024, while CGT financing decreased by 13% year-on-year.

In the past two years, the global monetary environment has entered a tightening cycle, with a large amount of venture capital and private equity preferring to invest in more stable and high-certainty biopharmaceutical sub-sectors, while maintaining caution towards CGT, which has a longer cycle and higher technical and clinical risks, even beginning to retreat.

On the demand side, CGT is still exploring broader indications and more mature commercialization paths; the cooling of capital has put companies under more severe budget pressure in R&D and clinical trials. As a result, the overall industry prosperity has declined, and some companies can only slow down or even freeze certain projects.

However, the weakening of industry financing is just one aspect.

The biggest advantage of CGT lies in its "customization," with its core technology largely based on patients' autologous cells or individual genomic information carrying disease-related mutations. Because of this, such information is very sensitive and is subject to increasingly stringent global regulations.

For example, due to national security and personal privacy protection considerations, many countries have implemented strict restrictions on the cross-border flow of biological information, even prohibiting the export of biological samples and important genetic data.

For innovative drugs that require multinational R&D and commercialization, such regulations not only significantly raise compliance thresholds but also lead to a sharp increase in the demand for "localized production." Companies are forced to establish factories or technology platforms in target markets to meet local regulatory agencies' real-time monitoring requirements for production processes, data management, and clinical trials.

In addition, autologous cell therapies require highly personalized collection, preparation, and production processes. This means that it is difficult to expand production according to the large-scale industrialization model of traditional drugs. Individualization implies high costs, complex process management, and a strong reliance on expert teams. From the perspective of payers and regulatory agencies, how to promote these cutting-edge treatments within economically bearable limits has always been a global challenge.

Solving Problems, Everything for Patients

In recent years, WuXi AppTec has helped numerous patients achieve better treatment outcomes through its global platform and "integrated" service model, leveraging continuously leading technology.

Chris White, an American, is one such patient struck by a "rare cancer." He was diagnosed with stage IV anal mucosal melanoma at the age of 36, which is rare and highly malignant. Initially, he thought the lump he discovered was hemorrhoids, but unexpectedly, the tumor had already spread to the lymph nodes, lungs, liver, and kidneys. He tried surgery, chemotherapy, immunotherapy, and targeted therapy at multiple hospitals, but the results were unsatisfactory A bout of colitis forced him to pause immunotherapy, as time continued to slip away amidst the progression of inflammation and the depletion of steroid dosage.

Until October 2019, Chris had the opportunity to participate in a TIL (tumor-infiltrating lymphocytes) clinical trial. By extracting and expanding immune cells from tumor tissue in vitro, and then reinfusing them back into the body, TIL holds promise in helping the body quickly recognize and engulf cancer cells. Fortunately, Chris's condition improved rapidly within months, and by early 2021, doctors announced that his cancer had "completely disappeared."

The "unsung hero" supporting the successful approval and market launch of this therapy (to be launched by Iovance in 2024) is WuXi ATU, a subsidiary of WuXi AppTec focused on cell and gene therapy. Its Philadelphia base is not only adjacent to Iovance but has also been providing comprehensive support for research, clinical, and commercial production to the company since 2015. It is this well-established supply chain that allows many "emerging pharmaceutical companies" to focus on innovation while providing life opportunities for patients like Chris White, who were previously "untreatable."

Similar cases are not uncommon. Kyverna Therapeutics publicly stated that WuXi AppTec is its sole supplier for the production and testing of its autoimmune cell therapy (KYV-101), and if they are forced to "cut supply," it would be difficult to find equivalent and affordable services within the United States. Another company engaged in innovative tumor therapies, Wugen, described that "although many vendors claim they can do cell production, the actual results may vary significantly."

In other words, when technology, talent, and supporting facilities are so scarce, any political or administrative intervention could cause patients to lose the most precious opportunity for treatment. Biopharmaceutical investor Steven Altschuler has also called out in local media in Philadelphia: if WuXi AppTec's production support is "cut off," there will be no quick way to fill this gap in capital, knowledge, and experience in the U.S., Europe, or Asia in the short term.

The biomanufacturing safety bill and regulatory controversies may seem grand, but the ones truly affected are these patients—individual lives.

Not a simple business "divestment," but ensuring the continuous operation of the business and eliminating uncertainty for patients and clients

Only by fully understanding this background can one comprehend WuXi AppTec's unusual decision to sell its ATU business in the U.S. and the U.K.—largely to eliminate policy risks and ensure that client projects on the ATU platform continue to progress smoothly, avoiding the impact of administrative intervention/regulatory intensification on patient interests.

It is worth noting that WuXi AppTec did not simply "divest" the ATU business but chose Altaris, an investment firm with a clear philosophy of "improving healthcare systems and patient outcomes."

Altaris has focused on the healthcare sector for many years, emphasizing capital investment to help healthcare companies enhance efficiency and innovation levels, thereby allowing more patients to access advanced treatments. This aligns closely with WuXi AppTec's principle of "customer first, patient first," and WuXi AppTec views it as a guarantee for the technical personnel and scientific team of ATU to continue to leverage their expertise This transaction has limited impact on WuXi AppTec's revenue or profit in the short term. According to the announcement, from January to November 2024, the combined operating revenue of Advanced Therapies and Oxford Genetics is approximately RMB 980 million (unaudited), accounting for 2.4% of the company's audited operating revenue for the most recent fiscal year. However, through this transaction, WuXi AppTec has achieved a more important goal: to ensure that relevant patients can receive continuous support and maximize the elimination of uncertainty.

Progress is the foundation of sustainability

CGT is still constrained by high production costs and stringent biosafety reviews. However, many industry opinions believe that with continuous technological iterations, such as the progress of universal cell therapies (which can be standardized and mass-produced), many current regulatory or administrative barriers will be resolved by technological forces, and market demand and regulatory models will also upgrade accordingly.

Once universal therapies achieve large-scale commercialization, patient accessibility will be qualitatively improved.

The future of pharmaceutical research and development will undoubtedly enter an era of "diverse progress": small molecule drugs, large molecule biologics, new molecules (nucleic acids, mRNA, gene editing), cell therapies, and gene therapies will all play their respective advantages.

WuXi AppTec emphasizes "following molecules, following customers" precisely to provide the most comprehensive solutions for different technological routes within this integrated framework. When regulations gradually improve and technologies mature, it will also be the time for such versatile platforms to explode again.

Whether trade barriers or industrial protectionism, ultimately, it is difficult to resist the market drive formed by "technological progress + huge clinical demand," nor can it stop the sincere determination of the most dedicated practitioners in the innovative drug industry to support patient interests. From another perspective, the sudden increase in trade barriers and protectionism hinders the flow of innovation, leading to a reduction in innovative activities, and this trend will make everyone more reliant on those capable and scalable platforms.

Conclusion: Maintaining faith amidst setbacks, the advancement of CXO to meet the needs of different types of customers is unstoppable

Looking back over the past year, it has undoubtedly been a challenging and uncomfortable year for WuXi AppTec and the entire Chinese CXO industry. In fact, this is a microcosm of a process of orderly rebalancing, and the future is merely an era of coexistence between internationalization and localization. From the perspective of the pharmaceutical industry, diseases are a global issue, while some technologies and capabilities indeed need to be localized.

CXO companies must remain undaunted by external environmental disturbances, uphold their values and missions, and make the most pragmatic strategic choices. After all, in the life-related race of pharmaceuticals, not only is capital and technology needed, but companies must also adhere to their commitment to their mission and to patients.

When technology and demand explode again in the next window period, CXO companies like WuXi AppTec, which possess a global platform and a complete industrial ecosystem, will continue to be an indispensable force in driving pharmaceutical innovation and protecting patient welfare