Wuxi Biologics (Cayman), Inc.

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Lonza said it is expanding a facility in Visp, Switzerland, to house two extra manufacturing suites for bioconjugates, including ADCs, according to a Tuesday release. The expansion will open in 2028 and will create around 200 new jobs. WuXi Biologics is expanding its factory in Leverkusen, Germany, by adding a new sterile filling line for prefilled syringes, according to a Wednesday announcement. The new line will use isolator tech so that multiple syringe sizes can be filled at the same time at a rate of 400 syringes per minute. The expansion is expected to finish by 2026. Baxter Healthcare anticipates losing about $200 million in sales in the fourth quarter of 2024 due to the damage caused by Hurricane Helene. The company estimates it will lose around $40 to $50 million in its kidney care business, and also $150 to $160 million in sales from its medical products and therapies, the company said Friday. Repligen reported a revenue of $155 million in Q3 , up 10% compared to the same period last year, the company said Tuesday. The CDMO is actively looking for new M&A deals, CEO Tony Hunt said during its earnings call. Repligen is seeking “bigger targets” to diversify its offerings, he added. Forge Biologics will manufacture clinical trial assets for gene therapy company Affinia Therapeutics, the manufacturer said Wednesday. Forge will make Affinia’s cardiomyopathy drug, named AFTX-201, among other projects. Adragos has opened a new manufacturing line in Livron, France, to increase its capacity to 160 million ampoules per year. Cell and gene therapy manufacturer BioLife Solutions is divesting its pharma storage subsidiary SciSafe Holdings for $73 million in cash, according to a Tuesday release. Cellares has appointed former Legend Biotech exec Ossama Eissa as its new chief operating officer. Eissa most recently served as a general manager for cell and gene technologies at Legend and has held positions at Novartis and Lonza. GenScript Biotech is opening a new site in Sydney, Australia, to make mRNA, growth factors and proteins, the company said Sunday. Clinical-stage biotech Aravax has spun off a commercial manufacturing subsidiary, which will make peptides in the UK. Aravax will invest $10 million into the subsidiary over the next two years, the company said Thursday. Clinical-stage biotech Orano Med broke ground to a new facility in Haute-Vienne, France, the company said Thursday. The site will make the radioisotope thorium-228, which can be made into lead-212, for radiotherapies.

iStock, ffikretow As the Chinese contract manufacturer awaits the U.S. Senate’s consideration of the BIOSECURE Act, it has added 800 new customers in the first nine months of 2024, while being hit with a 2% revenue decline in the third quarter. With the BIOSECURE Act looming, WuXi AppTec released a business report on Monday, touting revenue and profit growth in the first three quarters of 2024 amid “external challenges” from the proposed legislation seeking to restrict American companies from working with Chinese firms. In addition to its new clients, the China-based CDMO said it was able to retain its existing active customer base of more than 6,000 companies. Most of its new contracts were early- or mid-stage projects, with only 20 commercial or Phase III assets secured so far this year, according to a company presentation . In total, WuXi AppTec added 915 molecules in the first three quarters of 2024. In Q3, WuXi AppTec recorded around $1.46 billion in total revenue, a 2% year-over-year decline. Almost all its business segments took a sales hit, most notably the company’s domestic drug discovery division which suffered a 78.2% decline in revenue. Meanwhile, its biggest division—WuXi Chemistry—grew 1.4% to bring in $1.1 billion in the quarter. Still, chairman and CEO Ge Li in a statement called the company’s Q3 performance “steady,” choosing to focus on its results excluding COVID-19 and touting 14.6% year-over-year growth in Q3. For the full year 2024, WuXi AppTec expects to generate $5.36 billion to $5.67 billion in revenue, with free cash flow of $840 million to $980 million. “Although the recently proposed U.S. legislation may create short-term uncertainty for the global pharmaceutical and life sciences industry, WuXi AppTec remains steadfast in ‘doing the right thing and doing it right,’” Li said, noting that the company will continue to “enhance our capabilities and capacity” to better support its customers in developing treatments for patients worldwide. WuXi AppTec’s financial results on Monday suggest for now that the CDMO is remaining resilient in the face of the BIOSECURE Act threat in the U.S.—its biggest market. The BIOSECURE Act, introduced in January 2024 , is aimed at keeping U.S. taxpayer dollars from biotech companies of national concern, particularly those aligned with the Chinese government. WuXi AppTec is explicitly named by the proposed legislation, alongside WuXi Biologics, Beijing Genomics Institute, MGI and Complete Genomics. Last month, the U.S. House of Representatives overwhelmingly passed the BIOSECURE Act, which moves on to the Senate for consideration and where strong bipartisan support is expected. Several industry players are strongly in favor of the bill—including the Biotechnology Innovation Organization and manufacturing service providers —but other analysts point to supply chain vulnerabilities that the legislation would potentially aggravate. A June 2024 report from GlobalData noted that nearly 50 U.S.-based companies currently have contracts with Chinese firms, and that the BIOSECURE Act could disrupt the supply of many drugs—both commercially available or in clinical trials.

WuXi Biologics (Cayman) Inc. (SEHK:2269) entered into the Equity Transfer Agreement to acquire remaining 30% stake in WuXi Vaccines (Cayman) Inc. from Shanghai Hile Bio-Technology Co., Ltd. (SHSE:603718) for approximately $110 million on August 29, 2024. The transaction is subject to the the parties having obtained necessary authorizations and approvals in relation to the Acquisition (including, but not limited to, if applicable, the approvals from the board of directors and shareholders as well as the relevant stock exchanges) and such authorizations and approvals remaining valid, Equity Transfer Agreement and any documents relating to the Acquisition having been duly executed and become effective, there being no material breach of any of the representations, warranties and undertakings by the parties under the Equity Transfer Agreement. As of June 30, 2024, WuXi Vaccines (Cayman) Inc. reported total common equity of $284.27 million. The transaction is expected to complete in 10 days. WuXi Biologics (Cayman) Inc. (SEHK:2269) completed the acquisition of remaining 30% stake in WuXi Vaccines (Cayman) Inc. from Shanghai Hile Bio-Technology Co., Ltd. (SHSE:603718) on October 23, 2024. As of August 29, 2024, the sale transaction has been reviewed and approved by the board of directors of the Buyer and Seller. All other necessary decision-making and approval procedures for the transaction has also been completed.