China-headquartered contract research, development and manufacturing organization (CRDMO) WuXi AppTec announced financial results for the first nine months of 2026 with total revenue up 38.6% year-on-year, while net profit jumped 62.4% during the period.

WuXi AppTec raised its full-year revenue guidance to between 61 billion yuan ($9.15 billion) and 61.9 billion yuan ($9.28 billion), up from a previous range of 58.5 billion yuan ($8.77 billion) to 60.5 billion yuan ($9.07 billion), with continuing operations revenue now expected to grow 40% to 42% year-on-year from a previous range of 35% to 39%.

“Driven by the greater success of multiple customers’ products, the strength of our unique CRDMO business model, and the exceptional performance of our global team, we maintained broad-based momentum and delivered strong growth across revenue, profit, and cash flow in the first three quarters of 2026,” Ge Li, chairman and CEO of WuXi AppTec, said in a statement.

WuXi AppTec’s revenue from small-molecule drug development and manufacturing services increased 65.6% in the first three quarters, while the company’s chemistry business generated year-on-year revenue growth of 51.5% over the same period.

In a Monday earnings call, Co-CEO Minzhang Chen said the growth of the CRDMO’s chemistry business — its largest segment — was “driven by steady pipeline progression to late stages, and the sequential ramp-up of new capacity.” Chen noted WuXi Apptec has “continued the process of optimization” of production processes and improvements as well as “enhanced capacity efficiency resulting from the growth of late-stage clinical and commercial projects.”

To support this momentum, Chen said the company is “accelerating” its proactive capacity planning.

In August, WuXi AppTec raised its 2026 capital expenditure (CapEx) guidance to between 7.5 billion yuan and 8.5 billion yuan to support additional drug substance and drug product manufacturing capacity in Asia, Europe, and the U.S. However, the CRDMO is now increasing its CapEx forecast to 8 billion yuan to 8.5 billion yuan, including initiation of a new active pharmaceutical ingredient (API) site in Changzhou, China ahead of schedule.

Chen said WuXi AppTec will continue to focus on its “unique integrated CRDMO core business” while accelerating the development of the company’s global capacity and capabilities.

In China, two new small molecule API plants at the CRDMO’s Taixing site are slated to become operational this year, and two additional plants focused on oligonucleotides, peptides, and phosphorodiamidate morpholino oligomer (PMO) production are currently under construction and expected to be operational in 2027.

A Singapore site is currently being built and will also be operational next year, boosting the company’s global API manufacturing network for both small molecules and oligonucleotides, peptides and related synthetic conjugates (TIDES drugs). Three new TIDES plants are under accelerated construction in Taixing and in Singapore. The two Taixing plants are scheduled to be operational in 2027, and the first TIDES plant in Singapore will be operational in 2028.

This month, WuXi AppTec opened a commercial-scale spray drying facility at its drug product manufacturing site in Couvet, Switzerland. The facility houses a PSD-4 spray dryer used to produce amorphous solid dispersions, a formulation approach designed to improve the oral bioavailability of poorly water-soluble drug compounds. Since WuXi AppTec acquired the Couvet site from Bristol Myers Squibb in 2021, it has doubled the manufacturing capacity.

In the U.S., WuXi AppTec will begin operations this year at a new 1.74 million-square-foot plant in Middletown, Delaware. The drug product site is slated to start operations in the fourth quarter of 2026 for oral solid dosage manufacturing, with plans to expand into sterile/injectable production in the fourth quarter of 2027.

1260H list, BIOSECURE Act and OMB

The investment in the Delaware site — the CRDMO’s largest U.S. facility — comes as WuXi AppTec continues its legal fight against the Department of Defense (DoD), which in June 2026 designated WuXi AppTec as a “Chinese military company” under Section 1260H of the BIOSECURE Act.

WuXi AppTec filed a June 11 lawsuit in the U.S. District Court for the District of Columbia, claiming DoD’s “unlawful” designation as a “national security threat” has “inflicted substantial reputational, commercial, and operational harm” to the CRDMO. In August, a U.S. judge granted WuXi AppTec’s motion for preliminary injunction to enjoin DoD from enforcing or implementing its 1260H list designation.

However, General Counsel Howard Wu acknowledged during yesterday’s earnings call with analysts that WuXi AppTec could still be named a biotechnology company of concern (BCC) under the BIOSECURE Act by the Office of Management and Budget (OMB).

OMB is expected to publish the BCC list, meeting statutory criteria related to foreign adversary control and national security risk, by the end of 2026. “So far, we are not aware of any proposed BCC designation or any notice made by the OMB,” Wu said.