Say goodbye to injectable weight loss? Eli Lilly's small-molecule oral weight loss drug approved in the U.S., domestic pharmaceutical companies are accelerating their pursuit.

The Daily Economic News Reporter: Chen Xing The Daily Economic News Editor: Zhang Yiming

On Wednesday, Eastern Time, Eli Lilly announced that its once-daily oral GLP-1 drug Foundayo (orforglipron) has been approved for market launch by the U.S. Food and Drug Administration (FDA). This is the world’s first oral small-molecule GLP-1 receptor agonist, marking the official entry of weight-loss drugs into the “oral small-molecule” era.

With the convenience of taking without dietary restrictions and the global supply capacity not limited by production bottlenecks, Lilly is directly challenging Novo Nordisk’s already marketed oral Wegovy. Boosted by this news, Lilly’s stock price surged over 5% intraday on Wednesday.

The world’s first approved oral small-molecule GLP-1 receptor agonist

This approval came only a few months after Lilly submitted its application to the FDA, which was fast-tracked through a “priority review” pathway for “national priority drugs.” This means Lilly’s launch of Foundayo is only about three months behind Novo Nordisk’s oral version of Wegovy.

Lilly announced that Foundayo will begin shipping through its direct sales platform LillyDirect next Monday and will be available “in the short term” at major pharmacies and telemedicine platforms. Regarding pricing, insured patients can pay as little as $25 per month with coupons; self-paying patients will pay between $149 and $349 per month depending on dosage. In comparison, Novo Nordisk’s oral Wegovy is priced at approximately $499 per month (out-of-pocket), making Lilly’s pricing strategy significantly more attractive.

Lilly emphasizes its product’s core advantage in ease of use. Unlike Novo Nordisk’s drug, which requires fasting on an empty stomach in the morning and waiting 30 minutes before eating or drinking, Foundayo has no such restrictions.

Foundayo is classified as a “small-molecule drug,” whereas Lilly’s Zepbound and Novo Nordisk’s Wegovy are “peptide drugs,” the latter with more complex manufacturing processes and more apparent production capacity constraints. Lilly CEO Dave Ricks stated, “Foundayo has good scalable manufacturing capacity, which will enable us to promote it globally from the start. Once approved by regulators, we are essentially capable of supplying worldwide.”

According to company disclosures, nearly $1.5 billion worth of drug inventory has been stockpiled. Lilly expects that within the next year, the drug will be approved in over 40 countries.

Lilly is accelerating the deployment of this drug in China. This year, Lilly announced plans to expand its supply chain capacity in China comprehensively, focusing on the production capacity of orforglipron. The investment combines internal expansion and external cooperation: on one hand, relying on Lilly’s Suzhou factory; on the other, forming a strategic partnership with Kanglong Chemical, with an initial investment of $200 million to support its technological development. Following this news, Kanglong Chemical’s A-shares surged over 8% intraday on March 12. Lilly China has submitted an application to the National Medical Products Administration (NMPA) by the end of 2025 for the approval of orforglipron for treating type 2 diabetes and obesity.

Novo Nordisk’s oral Wegovy is already on the market, and Hengrui’s two oral drugs are entering late-stage clinical trials

Novo Nordisk’s oral semaglutide was approved in the U.S. for weight management in December 2024, becoming one of the representative products in this field. Its Phase III clinical trial results showed that 25 mg oral semaglutide tablets achieved an average weight loss of 16.6%.

However, Novo Nordisk’s oral drugs face two main limitations: first, strict administration conditions—taking on an empty stomach in the morning and waiting 30 minutes before eating or drinking; second, limited production capacity, which has slowed its global rollout. Nonetheless, early demand exceeded expectations, with Novo Nordisk disclosing that prescriptions in March had already exceeded 600k.

Domestic pharmaceutical company Hengrui Medicine is accelerating its pace. Its investigational HRS-7535 tablets are conducting Phase III clinical trials for weight loss and type 2 diabetes. The Phase II weight loss study endpoint data show that, among Chinese adult obese subjects, after 26 weeks of treatment, the 180 mg dose group experienced a 9.36% reduction in body weight from baseline.

According to FactSet data, analysts project that by 2030, Foundayo’s sales will reach $14.79 billion. Ricks stated that, besides attracting patients who prefer oral medication or seek lower prices, Foundayo can also be used for “maintenance therapy”—that is, after patients lose weight with injections, they can maintain their weight with oral medication. Evan David Seigerman, an analyst at BMO Capital Markets, believes that the lower price and the convenience of “oral alternative to injections” will attract more potential patients to the market.

Cantor Fitzgerald analyst Carter Gould said that sales data are lagging indicators, and analysts will monitor prescription volumes to gauge market acceptance of the oral drug.

Daily Economic News