Eli Lilly (LLY.US) establishes a global weight loss drug strategy: replicating the successful model in the United States, but adopts a cautious attitude towards fast approval of new drugs.

Patrik Jonsson, the international head of business at Eli Lilly (LLY.US), stated on Wednesday that the company has become a leader in the weight loss drug market in Europe, Asia, and the Middle East and is poised to replicate its dominant position in the United States globally. He also mentioned that Eli Lilly is cautious about using the new fast-track approval process of the Food and Drug Administration (FDA) to review its experimental oral weight loss drug, Orforglipron. Jonsson said the pharmaceutical company is implementing a consumer-oriented business strategy, similar to its approach in the United States, including forming partnerships with telemedicine and digital platforms to reach patients purchasing weight loss medication out-of-pocket from countries like the UK, China, and the UAE. "We quickly learned the importance of focusing on consumers from the United States," Jonsson said. Eli Lilly is applying this model in markets such as Australia and China and has established partnerships with e-commerce giants Alibaba Group Holding Limited Sponsored ADR and JD.com, Inc. Sponsored ADR Class A. This year, Eli Lilly launched the weight loss drug Mounjaro in Mexico, Brazil, India, and China. Jonsson mentioned that Eli Lilly delayed the launch of Mounjaro in some regions to ensure supply stability. He stated that Eli Lilly is fully capable of rapidly increasing the supply of Mounjaro in multiple markets because the company produces various forms of medication, including auto-injection and bottled forms. The global demand for weight loss drugs has surged, putting significant pressure on the supply chains of Eli Lilly and Novo Nordisk A/S. Jonsson also mentioned on Wednesday that it is too early to assert that the company will use the FDA's new fast-track review program for its experimental weight loss drug, Orforglipron. Jonsson said, "Our understanding of this type of priority approval voucher is currently very limited. I don't think we will use this program because we don't fully understand its content." In July, the FDA introduced the "Acting Commissioner's Priority Review Voucher" program, aiming to significantly shorten the review time for eligible drugs from the usual 10 to 12 months to 1 to 2 months. Several Wall Street analysts this week suggested that the oral weight loss drug Orforglipron is likely a leading candidate for the program, as the cost burden of expensive injectable weight loss drugs is increasing, and Eli Lilly is expanding its production scale in the United States. Analysts predict that the annual sales of this oral weight loss drug could reach peak sales of $10 billion and is expected to obtain FDA fast-track approval by the end of 2025. Jonsson stated that Eli Lilly must study the regulatory scheme but emphasized that the company's fundamental plan does not rely on the yet-to-be-determined priority approval voucher program. He also added that Eli Lilly plans to submit Orforglipron for approval to regulatory agencies in the US, UK, EU, Japan, and China within "a few weeks." Jonsson refused to disclose specifics about the location of drug production outside the US but confirmed plans to manufacture outside the US. He said, "We have a large production network outside the US specifically for the production of Orforglipron." He also added that producing tablets is simpler than injections because there is less reliance on cold chains. Wall Street is closely watching Eli Lilly's plan to launch Orforglipron, in part because its Danish competitor Novo Nordisk A/S is also developing an oral weight loss product expected to receive approval from US regulatory agencies later this year.