WuXi AppTec Co., Ltd.

SHANGHAI, March 31, 2025 /PRNewswire/ -- WuXi AppTec, a global company that provides a broad portfolio of R&D and manufacturing services to enable companies in the pharmaceutical and life sciences industry, today announced that its Active Pharmaceutical Ingredient (API) manufacturing sites at Changzhou and Taixing in Jiangsu province of China, successfully passed U.S. Food and Drug Administration (FDA) inspections back-to-back in March — both without a single observation and with no Form 483 issued. These achievements further demonstrate WuXi AppTec's unwavering commitment to upholding the highest quality standards and to supporting global healthcare innovators in reliably delivering needed therapies to patients worldwide. Continue Reading The Company's API site at Changzhou underwent a GMP surveillance inspection by the FDA that began on March 4. Covering 21 FDA-approved products, the inspection followed the FDA's six-system inspection model. The FDA inspectors concluded the review one day ahead of schedule. No observation was raised. On March 21, 2025, the API site at Taixing also completed a Pre-Approval Inspection (PAI) for the commercial manufacturing of a peptide-based therapeutic, with no observation. The site presented its state-of-the-art infrastructure, the team's strong technical expertise, and the high level of compliance demonstrated through its systems, documentation, and records. Operational since September 2023, the 169-acre Taixing site is the company's newest and largest API manufacturing facility. The successful inspection confirms the site's readiness to support commercial API supply to the global market. "Our team's consistent focus on quality and compliance is key to enabling our global partners," said Dr. Minzhang Chen, Co-CEO of WuXi AppTec. "We're pleased that both the Changzhou and Taixing sites passed their FDA inspections with no observation. These successful results further reinforce WuXi AppTec's dedication to providing high-quality R&D and manufacturing solutions that support our customers worldwide in accelerating new drug development and commercialization for the benefit of patients." The Changzhou and Taixing sites are critical manufacturing bases of WuXi STA, the company's small molecule CDMO platform, and WuXi TIDES, which provides integrated CRDMO services for oligonucleotides, peptides, and synthetic conjugates. Both sites support the manufacturing of APIs and intermediates across a wide range of chemical modalities. WuXi AppTec continues to invest in capacity expansion to meet growing global demand. The company's investment in its Couvet, Switzerland, site resulted in doubling oral dose capacity over the course of 2024. Meanwhile, WuXi AppTec continued to build its U.S. (Middletown, DE) site, which is expected to commence operations by the end of 2026. In May 2024, the company announced the groundbreaking of Singapore R&D and manufacturing site; Phase I expects to commence operations in 2027. About WuXi AppTec As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the global pharmaceutical and life sciences industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec's integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received an AA ESG rating from MSCI for the fourth consecutive year in 2024 and its open-access platform is enabling around 6,000 customers from over 30 countries to improve the health of those in need – and to realize the vision that "every drug can be made and every disease can be treated." Please visit: SOURCE WuXi AppTec WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

WuXi AppTec and WuXi Biologics specifically were put under pressure last year with the introduction of the BIOSECURE Act, the future of which remains in limbo. Shortly after WuXi AppTec provided an upbeat outlook for 2025, several other WuXi sibling companies are coming forward with their own 2024 success stories and ambitions for the year to come.First to report this week was bioconjugate CRDMO WuXi XDC, which spun off from WuXi Biologics in 2023. Over the course of 2024, the company logged roughly 4.05 billion Chinese yuan ($559 million) in total revenues, representing an impressive 90.8% jump over the 2.12 billion yuan it generated in 2023.WuXi XDC credited that growth to a spike in customer projects in both antibody-drug conjugates (ADCs) and the broader bioconjugation scene, as well as the steady progression of the company’s projects into later stages of development.In a sign of the company’s success, WuXi XDC noted that 13 of the top 20 global pharmaceutical companies by 2023 revenue have partnered with the contractor on projects at various stages. Overall, the company boasts a rolodex of 499 cumulative customers, WuXi XDC said in a press release Monday.Specificially, the company’s total number of integrated ADC projects reached 177 last year, while broader bioconjugate projects—which WuXi refers to as XDC projects—climbed to 17. Given last year’s momentum, WuXi XDC continues to scale up its business.Alongside capacity expansions planned to go live in 2025 and 2027, the company is touting the expected completion of a new manufacturing site in Singapore by the end of the year. Unveiled last year, the Singapore site will include manufacturing lines for monoclonal antibody intermediate, drug substance and drug product. The site will also house quality control labs and warehouse space.WuXi XDC did not provide formal guidance for the remainder of 2025, though the company’s CEO, Jimmy Li, stressed in a statement that he believes the CRDMO will “continue to win customers, and increase our market share going forward.” WuXi BiologicsAside from WuXi XDC, the company’s contracting sibling WuXi Biologics also touted solid 2024 performance this week, tallying 9.6% year-over-year sales growth to nearly 18.7 billion yuan ($2.6 billion). Taking COVID-related projects out of the mix, WuXi Biologics total 2024 revenue grew 13.1% year over year, the company said Tuesday.Among several other wins last year, WuXi Bio pointed to the swift growth of certain technology platforms in its portfolio, such as ADCs and bispecific antibodies, as well as recent capacity expansions and a production ramp-up in Europe.All told, the company added 148 new development projects in 2024, spanning bispecific and multispecific drugs, ADCs, fusion proteins and vaccines. On the manufacturing front, the company last year chipped in on 66 late-stage projects and 21 commercial production projects unrelated to COVID. At the same time, WuXi Bio says it knocked out 16 process performance qualification (PPQ) projects and has another 24 scheduled for 2025.At the end of last year, WuXi Bio says it had amassed a total backlog of $18.5 billion, made up of $10.5 billion in service bids and $8 billion in potential milestones. That said, the company’s decision earlier this year to sell a vaccine plant in Dundalk, Ireland, to Merck & Co. hived $3 billion off that services backlog total, WuXi Bio noted in its earnings release.For the year to come, WuXi Bio’s CEO Chris Chen said he expects his company to chart “accelerated and profitable growth in 2025 and beyond.”The updates from WuXi Bio and WuXi XDC follow WuXi AppTec’s announcement last week that the CRDMO giant’s total 2024 sales had slipped slightly to 39.25 billion yuan ($5.4 billion). Nevertheless, the company is keeping its head up and expects to deliver sales growth between 10% and 15%, or roughly 41.5 billion yuan ($5.7 billion) to 43 billion yuan ($5.9 billion) in total this year.WuXi AppTec and WuXi Biologics specifically were put under pressure last year with the introduction of the BIOSECURE Act, which sought to block federal contracts with five named life sciences companies from China over alleged national security concerns.While the bill rallied support from both Republicans and Democrats, it generally proved less popular among the biopharma industry itself, with some decrying the legislation as politically motivated. After failing to be included in a key defense spending bill late last year, BIOSECURE’s current fate looks uncertain.Still, new unknowns, like the ultimate fallout from China trade tariffs recently imposed by President Donald Trump, could continue to hang over the success of the WuXi family of companies. 

AstraZeneca and Alteogen's subcutaneous drug delivery deal, Taiho's acquisition of an ADC biotech and WuXi AppTec's 2025 growth projection made our news this week. AstraZeneca has tapped Korea's Alteogen to develop subcutaneous cancer drugs. Taiho Pharmaceutical is paying $400 million to acquire antibody-drug conjugate expert Araris Biotech. WuXi AppTec expects sales to grow 10% to 15% in 2025 as the fate of the BIOSECURE Act remains uncertain. And more.1. AstraZeneca signs Alteogen deal worth up to $1.35B for subcutaneous cancer drugs despite Merck-Halozyme patent dramaAstraZeneca has enlisted Alteogen and its hyaluronidase technology, ALT-B4, to advance subcutaneous formulations of “several oncology assets.” In its filings to the Korea Exchange, Alteogen disclosed two separate agreements together potentially worth up to $1.35 billion. The deal comes as Halozyme is engaged in a patent dispute with Merck & Co. on its subcutaneous formulation of Keytruda, which also uses ALT-B4.2. Otsuka's Taiho pays $400M for Swiss partner to 'turbocharge' 3 ADCs to clinicTaiho Pharmaceutical is paying $400 million upfront and committing up to $740 million in milestones to acquire Swiss antibody-drug conjugate specialist Araris Biotech. In 2023, the Otsuka unit inked a licensing deal to use Araris’ AralinQ platform to develop ADCs. Araris has three preclinical programs expected to enter the clinic over the course of 2025 and 2026.3. WuXi AppTec offers rosy 2025 guidance despite threat of US-China trade tensionsWuXi AppTec expects to grow sales by 10% to 15% in 2025. The rosy projection comes as the fate of the BIOSECURE Act remains uncertain. The company’s revenue slipped about 3% to 39.24 billion Chinese yuan ($5.4 billion) last year. Nevertheless, U.S. sales, which made up the bulk of the CRDMO’s business, still grew nearly 8% despite the draft bill’s threats of forced industry decoupling.4. Curevo rounds up $110M to challenge GSK’s Shringrix, nabs Moncef Slaoui to lead boardCurevo Vaccines, founded and invested in by Korea’s GC Biopharma, has raised $110 million in series B led by new investor Medicxi. OrbiMed, Sanofi Ventures and HBM Healthcare Investments also joined as new backers of the U.S. biotech. The money will be used on a phase 2 extension program for amezosvatein, a potential competitor to GSK’s blockbuster shingles vaccine Shingrix.5. Elevation drops sole clinical-stage ADC over poor phase 1 data, lays off 70% of staffElevation Oncology has decided to ditch its sole clinical asset, a Claudin18.2 antibody-drug conjugate coded EO-3021, which it licensed from China’s CSPC Pharma for $27 million upfront in 2022. Elevation unveiled lackluster tumor response data from a small group of stomach patients last year but pressed on by focusing on a subgroup. Updated data only showed a 22% response rate among those biomarker-enriched patients.6. AstraZeneca offers early look at Datroway-Tagrisso combo in EGFR lung cancer as phase 3 trial rolls onAstraZeneca found that a combination of its Daiichi Sankyo-partnered Datroway and Tagrisso induced a 36% response rate in a small group of patients with EGFR-mutated non-small cell lung cancer (NSCLC) who had progressed on first-line Tagrisso, according to results from the phase 2 Orchard trial. The two companies in October launched a phase 3 trial to test Datroway either alone or together with Tagrisso in post-Tagrisso NSCLC.Other News of Note:7. Dr. Reddy’s, Sun Pharma and Zydus issue US recalls, citing failed specs and labeling issues8. Chiesi bails on TiumBio’s respiratory drug deal (Korea Biomedical Review)9. Klick buys Ward6 Singapore’s operations to fuel Asian expansion10. Japan’s RegCell moves to US with $45.8M to advance Treg platform (release)