Obesity Today: Chugai licenses CT-388 for Japan, GLP-1 access news (Oct 7–14, 2025)

LucidQuest

4 weeks ago

Obesity news this week include Chugai in-licensing Roche’s dual incretin CT-388 for Japan after encouraging Phase 1 weight-loss data and an ongoing Phase 2 trial in obesity with type 2 diabetes. At the same time, global GLP-1 access drew attention as the Bill Gates Foundation and PAHO launched efforts to expand availability in lower-income countries amid the rise of semaglutide generics.

🇯🇵 Chugai licenses Roche’s dual agonist CT-388 for Japan 💊 [1] [10 Oct 2025]

https://www.chugai-pharm.co.jp/english/news/detail/20251010170000_1186.html
Context: Overseas Phase 1 (24-week weekly SC) in adults with obesity; placebo-adjusted mean weight change −18.8% at week 24; GI AEs mostly mild to moderate; Phase 2 ongoing in obesity with T2D.
Key point: Chugai obtained exclusive Japan rights to develop and market CT-388, paying upfront and milestones to Roche.
Implication: May influence prescriber choice and payer reviews pending full data.

🗓️ Ascletis advances once-monthly ASC35 dual agonist to clinic [2]

https://www.prnewswire.com/news-releases/ascletis-selects-a-best-in-class-once-monthly-subcutaneously-administered-glp-1rgipr-dual-peptide-agonist-asc35-for-clinical-development-302581431.html
Context: In vitro potency reported ~4x tirzepatide for GLP-1R and GIPR; NHP PK half-life ~14 days with depot; DIO mouse showed higher weight loss vs tirzepatide (preclinical).
Key point: Ascletis plans a U.S. FDA IND submission for obesity in Q2 2026, positioning ASC35 for once-monthly dosing.
Implication: Signals pipeline investment and modality expansion.

🔎 Benzinga: Sciwind’s ecnoglutide IPO bid in Hong Kong [3]

https://www.benzinga.com/Opinion/25/10/48120249/tencent-and-meituan-backed-chinese-obesity-drug-maker-sciwind-eyes-hong-kong-ipo
Context: Article states ecnoglutide (XW003) is under NMPA review and cites Phase 3 data in *The Lancet Diabetes & Endocrinology*; overseas rights reportedly licensed with large potential deal value.
Key point: Benzinga reports Sciwind is seeking HKEX listing to fund commercialization of ecnoglutide, described as a biased GLP-1 RA.
Implication: Signals pipeline investment and modality expansion.

📉➕💊 Skye’s nimacimab misses mono, shows add-on benefit with Wegovy [4]

https://www.clinicaltrialsarena.com/news/skye-biosciences-nimacimab-obesity-phase-iib-trial/
Context: Phase IIa (26 weeks): nimacimab mono ~−1.52% vs placebo +0.26%; combination with Wegovy achieved −13.2% vs Wegovy mono −10.25%; no added GI or neuropsychiatric AEs reported.
Key point: Company highlights combo separation ~2.95% over Wegovy and plans to explore higher doses, per article.
Implication: May influence prescriber choice and payer reviews pending full data.

🌏 Lotus to commercialise semaglutide in multiple Asian markets [5]

https://www.biospectrumasia.com/news/25/26723/taiwans-lotus-pharma-to-commercialise-semaglutide-injection-for-obesity-in-multiple-asian-markets.html
Context: License and Supply Agreement with Adalvo covers obesity and diabetes injections; Lotus to seek first-to-market generic launches per regions noted.
Key point: Lotus says it has exclusive rights for Wegovy generic in South Korea, Taiwan, Thailand, Singapore, and Vietnam, with registrations to commence.
Implication: Introduces competition that may affect pricing and formulary access.

🌐 Reuters: Gates and PAHO eye access pathways for GLP-1s in LICs [6] [10 Oct 2025]

https://www.reuters.com/business/healthcare-pharmaceuticals/bill-gates-paho-consider-ways-bring-weight-loss-drugs-lower-income-countries-2025-10-10/
Context: Reuters reports semaglutide’s IP lapses in some countries next year, generics in development; PAHO’s fund aggregates demand to lower prices.
Key point: Gates Foundation and PAHO are considering efforts to expand access and generate data across populations.
Implication: Access programs may expand screening, initiation, and follow-up at scale.

Why it matters

Dual agonists and add-on strategies could broaden efficacy and tolerability options across obesity phenotypes.
Monthly dosing ambitions aim to reduce burden and improve adherence.
Asia-focused semaglutide commercialization may reshape competitive dynamics and timelines for affordability.
Policy actors exploring pooled procurement and evidence generation could accelerate access beyond high-income markets.
IPO and BD moves signal sustained capital flow into incretin and non-incretin obesity mechanisms.

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FAQ

What is CT-388 and who controls it in Japan?

CT-388 is a long-acting dual GLP-1/GIP receptor agonist from Roche. Chugai licensed exclusive Japan development and marketing rights, citing robust Phase 1 weight loss and ongoing Phase 2 in obesity with T2D [1].

When could Ascletis start U.S. clinical testing of ASC35?

Ascletis states it plans to submit an FDA IND in Q2 2026 for obesity. Current evidence is preclinical and early pharmacology, including NHP PK and DIO mouse efficacy vs tirzepatide, per company release [2].

What is Sciwind seeking with ecnoglutide?

Per Benzinga, Sciwind applied to list in Hong Kong to fund ecnoglutide (XW003), described as a biased GLP-1 RA under NMPA review, with referenced Phase 3 signals vs semaglutide in a journal report noted by the article [3] (endpoint specifics not provided).

Did Skye’s nimacimab work as a standalone?

In Phase IIa topline reported by Clinical Trials Arena, nimacimab monotherapy did not show meaningful weight loss vs placebo, but added ~2.95% weight loss over Wegovy when combined, with similar tolerability in reported domains [4].

Where will Lotus commercialise semaglutide injections?

Lotus says it will register semaglutide for obesity and diabetes in multiple Asian markets and holds exclusive rights for the Wegovy generic in South Korea, Taiwan, Thailand, Singapore, and Vietnam, via Adalvo partnership [5].

How might PAHO and Gates expand GLP-1 access?

Reuters reports exploration of pooled procurement and support for clinical data in diverse populations, as semaglutide generics emerge in some countries next year, to lower costs and broaden access in lower-income settings [6].

Entities / Keywords

Chugai Pharmaceutical; F. Hoffmann-La Roche; CT-388; GLP-1/GIP dual agonist; obesity; type 2 diabetes; Ascletis Pharma; ASC35; once-monthly dosing; tirzepatide comparator; Sciwind Biosciences; ecnoglutide (XW003); NMPA; Hong Kong IPO; Skye Biosciences; nimacimab; CB1 inhibitor; Wegovy (semaglutide); Lotus Pharmaceutical; Adalvo; semaglutide injection; PAHO; Bill & Melinda Gates Foundation; access programs; generics.