BioChaperone Lispro (THDB0206)
Adocia / Tonghua Dongbao
Beat Humalog after meals — in China, unpublished.
An investigational ultra-rapid mealtime insulin — the familiar lispro molecule reformulated with Adocia's BioChaperone excipient to speed absorption. In a 26-week phase 3 trial in China (550 adults with type 1 diabetes) it matched Humalog on HbA1c and beat it on post-meal glucose, with lower glucose an hour after every meal. But the evidence is a corporate topline release, not a published trial, the licence covers Asia only, and no regulator has been asked to approve it yet.
The scorecard
Mealtime convention (faster onset is better): the BioChaperone excipient is designed to accelerate lispro absorption, and in a 26-week phase 3 in type 1 diabetes glucose was statistically lower one hour after every meal versus Humalog — an early-action signal measured across a whole day of real eating, not a single clamp. Scored alongside (not above) Lyumjev because there is no published PK or head-to-head study against today's ultra-rapid insulins.[1]
Mealtime convention (earlier, front-loaded exposure is better): it significantly blunted the glucose rise after a standard meal versus Humalog, which implies action is front-loaded. No clamp tmax or early-exposure ratios have been published, so this is inferred from the glucose result rather than measured directly.[1]
Mealtime convention (shorter tail is better): faster front-loading usually implies a shorter tail, but no duration-of-action data have been reported at all. This score is an inference, not a finding — treat it as provisional.[1]
Far more real-world exposure than the Arecor candidates — 550 adults with type 1 diabetes dosing at every meal for 26 weeks, with adverse events mostly mild-to-moderate and comparable to Humalog. Marked down hard because absorption variability has never been reported and the results exist only as a company topline release with no peer-reviewed publication.[1]
No exercise or hypoglycemia-flexibility data have been reported. A faster, shorter bolus should in principle leave less insulin on board around activity, but that is inference; scored neutral.
Access convention (cheaper and more available is better): not approved or sold anywhere. Licensed to Tonghua Dongbao for China and other Asian markets only, and as of Adocia's Q1 2026 update the Chinese marketing authorisation filing was still "in preparation" — not submitted. No US, EU or UK development programme has been announced, so most readers of this site could not get it even if China approves.[3]
Insulins are scored relative to their role peers (see tags: rapid, ultra-rapid, basal, inhaled). A basal insulin's onset score compares it to other basals, not to mealtime insulins.
The full picture
BioChaperone Lispro (development code THDB0206) is an ultra-rapid mealtime insulin: the same insulin lispro molecule as Humalog, reformulated with BioChaperone, a proprietary excipient from the French biotech Adocia that is designed to speed how quickly insulin crosses from the injection site into the blood.1 The goal is the same one Fiasp and Lyumjev chase — get insulin working fast enough to blunt the glucose spike from a meal, instead of arriving late and chasing it.
The type 1 result. In October 2025, Adocia and its Chinese partner Tonghua Dongbao announced topline results from a 26-week phase 3 trial in China: 550 adults with type 1 diabetes on multiple daily injections, randomised against Humalog.12 It met its primary endpoint — HbA1c reduction comparable to Humalog (non-inferiority) — and met its key secondary endpoint: a statistically significantly smaller rise in blood glucose after a standard meal. Glucose was statistically lower one hour after each meal — breakfast, lunch and dinner. Adverse events were mostly mild-to-moderate and comparable to Humalog.
That is a genuinely useful shape of evidence. Most ultra-rapid candidates on this site — Arecor's AT247 and AT278 — have only single-dose clamp studies behind them. This one has half a year of real people eating real meals. On T1D maturity, it is the most advanced ultra-rapid insulin in development that is not already on the market.
Now the honest caveats, and they are large.
- This is a press release, not a paper. As of July 2026 the type 1 phase 3 has not been published in a peer-reviewed journal and has not been presented at a conference. Everything above comes from a corporate topline announcement.2 We have no numbers for the size of the post-meal benefit, no PK or clamp data, no time-in-range figures, and no absorption-variability data. Our onset, peak and tail scores are therefore inferences from a glucose result — not measurements — and we have scored them conservatively for that reason. If you compare them to our Lyumjev or Fiasp scores, remember those rest on published clamp studies and this one does not.
- Beware the type 2 data crossing over. Adocia held a virtual KOL event on 16 June 2026 and presented a poster at ADA in June 2026 — both covered the type 2 diabetes phase 3 (NCT05834868, topline announced July 2025), not the type 1 trial.3 Coverage sometimes blurs the two. The type 1 readout remains the October 2025 topline and nothing more.
- It is not filed anywhere. As of Adocia's Q1 2026 business update (12 May 2026), the Chinese marketing authorisation filing was described as "in preparation" and is Tonghua Dongbao's responsibility.3 No submission to the Chinese regulator has been publicly confirmed. Adocia earns a US$20 million milestone if approval is obtained in China — on approval, not on filing.
- The licence is Asia-only. Tonghua Dongbao holds the rights for China and other Asian markets under a 2018 agreement.3 There is no US, EU or UK development programme. For most people reading this site, that is the decisive fact: even a Chinese approval would not put this insulin in your pharmacy. It is why its access score sits near the floor.
Why we track it anyway. The insulin-speed gap is the hard physical ceiling on closed-loop control: algorithms can decide in seconds, but subcutaneous insulin takes an hour or more to do its work. Every credible attempt to shrink that lag matters — and a 550-person, 26-week phase 3 in type 1 diabetes showing lower glucose after every single meal is a more meaningful attempt than most. What it needs next is publication, a filing, and a Western partner. Until then, treat it as promising and unproven.
References
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PharmaTimes. Ultra-rapid insulin shows promise in phase 3 trial for type 1 diabetes. PharmaTimes (15 Oct 2025). https://pharmatimes.com/news/ultra-rapid-insulin-shows-promise-in-phase-3-trial-for-type-1-diabetes/ ↩ ↩2
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Adocia and Tonghua Dongbao. Positive topline results of the phase 3 clinical trial of ultra-rapid insulin BioChaperone Lispro (THDB0206) in people with type 1 diabetes. Company press release, mirrored on Euronext company news (15 Oct 2025). https://live.euronext.com/en/products/equities/company-news/2025-10-15-adocia-and-tonghua-dongbao-announce-positive-topline ↩ ↩2
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Adocia. Press releases and publications (Tonghua Dongbao licence; Q1 2026 business update, 12 May 2026; 16 June 2026 KOL event on the type 2 diabetes phase 3 results). Adocia (accessed July 2026). https://www.adocia.com/medias-publications/ ↩ ↩2 ↩3
Coming soon
ETA · Phase 3 complete and positive in both type 1 and type 2 diabetes in China. Licensed to Tonghua Dongbao for China and other Asian markets (2018 agreement). As of Adocia's Q1 2026 business update the Chinese marketing authorisation filing was still in preparation — no submission has been publicly confirmed — and no US, EU or UK development programme has been announced.
- →Chinese marketing authorisation filing, which is Tonghua Dongbao's responsibility; Adocia earns a US$20M milestone if and when approval is obtained, plus royalties · Filing "in preparation" as of May 2026; no date announced
- →Publication or conference presentation of the type 1 phase 3 results — still absent. The June 2026 KOL event and ADA poster covered the TYPE 2 data
- →A US or EU development partner. Without one, this insulin will not reach Western pharmacies at all
Sources
- [1]Ultra-rapid insulin shows promise in phase 3 trial for type 1 diabetes (BioChaperone Lispro / THDB0206) · news · 2025-10-15 — Trade-press write-up of the topline announcement: 550 Chinese adults with type 1 diabetes, 26 weeks, versus Humalog. Primary endpoint met (non-inferior HbA1c); key secondary met (significantly lower glucose rise after a standard meal). Topline only — not peer-reviewed, not presented.
- [2]Adocia and Tonghua Dongbao announce positive topline results of the phase 3 trial of BioChaperone Lispro (THDB0206) in people with type 1 diabetes · manufacturer · 2025-10-15 — Euronext company-news mirror carrying the full text of the Adocia press release. A corporate announcement, not a data publication — the underlying trial has not been published or presented.
- [3]Adocia — press releases and publications · manufacturer — Adocia's press-release index. Source for the Tonghua Dongbao licence (China and other Asian markets), the Q1 2026 business update (12 May 2026) stating the Chinese marketing authorisation filing is "in preparation", the milestone terms, and the 16 June 2026 KOL event — which reviewed the TYPE 2 diabetes phase 3 results, not the type 1 results.