Endocrinology Today—November 4, 2025

This week’s endocrinology news brings you the most important developments, regulatory updates, and industry breakthroughs across biopharma.

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🧪 China OKs GenSci098 trial registration [1] [27 Oct 2025]

https://news.futunn.com/en/flash/19538578/changchun-high-new-subsidiary-s-gensci098-injection-granted-approval-for
Context: Changchun High & New said NMPA approved clinical trial registration for GenSci098, a Category 1 new biologic.
Key point: GenSci098 blocks TSH receptor autoantibodies to reduce thyroid hormone synthesis and relieve hyperthyroidism and exophthalmos (endpoint not specified).
Implication: Introduces competition that may affect pricing and formulary access.

🧬 NICE to adapt Monash-led PCOS guideline for UK use [2] [UK • 28 Oct 2025]

https://www.miragenews.com/nice-to-adapt-monash-led-pcos-guideline-for-uk-1558620/
Context: 2023 International PCOS Guideline, developed across 71 countries, will be NICE’s first formal adaptation.
Key point: Agreement enables evidence-based PCOS care aligned to UK needs, without altering global use elsewhere (specific UK changes not stated).
Implication: May expand screening, initiation, and follow-up at scale.

🦴 FDA: Conexxence/Bomyntra (denosumab-bnht) are interchangeable [3] [29 Oct 2025]

https://www.businesswire.com/news/home/20251028528458/en/FDA-Grants-Interchangeable-Designation-to-Fresenius-Kabis-Biosimilars-Conexxence-and-Bomyntra-denosumab-bnht
Context: Fresenius Kabi’s denosumab-bnht biosimilars now interchangeable with Prolia and Xgeva for approved indications; boxed warning and REMS apply.
Key point: Interchangeability allows pharmacy-level substitution per state law, potentially lowering costs.
Implication: Introduces competition that may affect pricing and formulary access.

🌗 ESE issues menopause/perimenopause guideline [4] [29 Oct 2025]

https://www.contemporaryobgyn.net/view/new-guidelines-on-menopause-and-perimenopause-management-released
Context: Clinical Practice Guideline published 04 Oct 2025 in European Journal of Endocrinology; endorsed by multiple societies.
Key point: Recommends spectrum view of menopause, targeted diagnostics, and management including POI guidance (metrics not detailed here).
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

💉 Tirzepatide tops global drug sales YTD 2025 [5] [30 Oct 2025]

https://www.statnews.com/2025/10/30/eli-lilly-zepbound-mounjaro-bestselling-obesity-drug/
Context: Lilly reported Q3 tirzepatide sales of $10.1B, $24.8B YTD; Merck’s Keytruda at $23.3B YTD.
Key point: Tirzepatide, sold as Mounjaro and Zepbound, is now the world’s best-selling medicine YTD 2025.
Implication: May influence prescriber choice and payer reviews pending full data.

🤳 AI flags early acromegaly via facial analysis [6] [30 Oct 2025]

https://medicalxpress.com/news/2025-10-ai-early-facial-patients-acromegaly.html
Context: IGTP team’s “AcroFace” analyzed 118 images; highlighted by Pituitary.
Key point: Reported 93% accuracy in identifying acromegaly in a preliminary sample; larger pilot underway.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🦴 FDA: Celltrion’s STOBOCLO/OSENVELT interchangeable [7] [30 Oct 2025]

https://www.prnewswire.com/news-releases/us-fda-grants-interchangeability-designation-to-celltrions-denosumab-biosimilars-stoboclo-denosumab-bmwo-and-osenvelt-denosumab-bmwo-302599537.html
Context: FDA granted interchangeability to denosumab-bmwo for Prolia/Xgeva indications across all approved uses.
Key point: Designation supported by comparative clinical and analytical data, enabling pharmacy substitution per state law.
Implication: Introduces competition that may affect pricing and formulary access.

🇨🇦 Diabetes Canada launches anti-stigma campaign [8] [Canada • 30 Oct 2025]

https://www.globenewswire.com/news-release/2025/10/30/3177318/0/en/Diabetes-Canada-launches-campaign-to-combat-harmful-myths-and-misinformation.html
Context: New survey shows persistent misconceptions about diabetes causation and management.
Key point: Campaign targets blame and misinformation, including myths around sugar intake and medication “failure.”
Implication: May expand screening, initiation, and follow-up at scale.

🧲 Magnetic mitohormesis signals benefit in T2D subgroup [9] [31 Oct 2025]

https://medicalxpress.com/news/2025-10-magnetic-field-therapy-mimicking-benefits.html
Context: SGH/NUS exploratory study, 40 adults with poorly controlled T2D; weekly PEMF leg sessions for 12 weeks.
Key point: No overall glycemic change, but central-obesity subgroup saw HbA1c drop from 7.5% to 7.1% with high responder rate.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

📱 AI-led DPP matches human-led outcomes in RCT [10] [31 Oct 2025]

https://www.salutedomani.com/2025/10/31/ai-powered-diabetes-prevention-program-shows-similar-benefits-to-those-led-by-people/
Context: Johns Hopkins phase III RCT, 368 adults with prediabetes; yearlong AI app vs four remote human-led programs.
Key point: 31.7% vs 31.9% met CDC composite benchmark; AI arm had higher initiation and completion.
Implication: DTC/telehealth could streamline initiation and adherence via remote prescribing and logistics.

Why it matters

Denosumab interchangeability across two sponsors could accelerate US payer adoption and pharmacy substitution.
Guideline moves in PCOS and menopause point to more standardized, evidence-based endocrine care.
GLP-1/GIP market momentum is reshaping global revenue leadership and access debates.
Early-detection AI and noninvasive metabolic interventions hint at scalable endpoints, but require larger trials.

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FAQ

What is GenSci098 and what did China approve?

GenSci098 is a Category 1 biologic from Jin Sai Pharmaceutical that blocks TSH receptor autoantibodies for diffuse toxic goiter. NMPA approved its clinical trial registration in China [1].

What does NICE’s adaptation mean for PCOS care in the UK?

NICE will adapt the 2023 International PCOS Guideline led by Monash, making it the first formal NICE guideline adaptation, aiming to localize evidence-based recommendations for UK services [2].

Which denosumab biosimilars received US interchangeability?

Fresenius Kabi’s Conexxence and Bomyntra (denosumab-bnht) and Celltrion’s STOBOCLO and OSENVELT (denosumab-bmwo) were designated interchangeable with Prolia and Xgeva for approved uses [3][7].

How dominant is tirzepatide commercially in 2025?

Per STAT, tirzepatide posted $10.1B in Q3 and $24.8B YTD 2025, surpassing Keytruda’s $23.3B YTD, making it the best-selling drug YTD 2025 [5].

How strong is the evidence for AI in acromegaly screening?

Preliminary only: a 118-person study reported 93% accuracy. Larger, diverse-population studies are in progress to validate real-world performance [6].

Do magnetic mitohormesis and AI-DPPs replace standard care?

Not yet. The PEMF study was small with subgroup signals, and the AI-DPP RCT showed noninferior benchmarks with better engagement, suggesting options rather than replacements pending broader validation [9][10].

Entities / Keywords

GenSci098; Changchun High & New; Jin Sai Pharmaceutical; TSH receptor; diffuse toxic goiter; NICE; Monash PCOS Guideline; Fresenius Kabi Conexxence, Bomyntra; denosumab-bnht; Prolia; Xgeva; European Society of Endocrinology; menopause guideline; Eli Lilly tirzepatide; Zepbound; Mounjaro; IGTP AcroFace; Celltrion STOBOCLO, OSENVELT; denosumab-bmwo; Diabetes Canada; stigma; SGH; NUS; magnetic mitohormesis; PEMF; Johns Hopkins AI-DPP; CDC benchmarks.