Tirzepatide: standalone registration of a Chinese API reshapes the segment

On 7 August 2026 Vademecum reported that the Russian Ministry of Health had granted Chinese manufacturer Hubei JXBio Pharmaceutical a marketing authorisation for the tirzepatide active pharmaceutical ingredient - a dual GLP-1/GIP receptor agonist used in type 2 diabetes and obesity. The API is registered as a powder supplied in packs of 0.05 to 2 kg. WIT Pharma managing partner Dmitry Klimchuk commented on the development for the publication.

Why this matters more than it seems

The appearance of yet another Chinese supplier is not big news in itself. What matters is different: the API is receiving standalone registration in Russia rather than 'riding along inside a finished-product manufacturer's dossier', as Dmitry Klimchuk noted in his comment for Vademecum. As long as an API exists only inside someone else's registration dossier, access to it is confined to a single production chain. Standalone registration opens the resource to the industry as a whole.

'For the market this is an acceleration - tirzepatide is turning from a product held by two or three closed-cycle companies into a competitive segment,' Klimchuk stressed. Any Russian tirzepatide manufacturer can now turn to the registered API supplier - both those whose products already hold marketing authorisations and those still preparing dossiers or running clinical trials.

Context: patent, generics, API scarcity

Eli Lilly's Eurasian patent on the molecule ceased to have effect in Russia in November 2024 - at the rights holder's own request. The originator product Mounjaro was never registered or officially procured in Russia, so the segment took shape as a generic one from the start. According to the State Register of Medicines, four tirzepatide products are registered in Russia: Tirzetta, Sejaro, Tirzero Slim and Tirlideya. Only Promomed runs a full production cycle, making the API at its own Biokhimik site; the others source it from Chinese operators. One more application is in the pipeline: in July 2025 R-Pharm obtained approval for a comparative pharmacokinetics trial of its RB-030 against Mounjaro, valid until the end of 2027.

Once patent protection had lapsed, the barrier in the segment was no longer intellectual property but access to a quality API. That is precisely the barrier standalone registration removes.

Asian pharma's standard entry play

'In essence, the company is entering Russia via the classic route for Asian pharma - not with a finished product and not with an office, but as the raw-material layer of someone else's production chain,' Klimchuk explained. This entry is fast and low-risk: it requires neither a local structure nor promotional investment, and the options then widen - up to supplying the API to the EAEU market under the same certificate.

For Asian manufacturers this is a working template for a first step into Russia and the EAEU: API registration creates a legally independent position in the supply chain and a base for the next stages - from contract manufacturing to registering finished products of their own. For Russian marketing authorisation holders, the emergence of independent registered API suppliers is a way to diversify sourcing and reduce dependence on a single source named in the dossier.

Sources

Vademecum, 'A Chinese pharma company is the first to register the tirzepatide API in Russia', 7 August 2026 (vademec.ru); State Register of Medicines (grls.rosminzdrav.ru); Eurasian Patent Organization data on patent termination (as reported by GxP News, Vademecum, Forbes); State Register / Vidal data on registered tirzepatide products; GxP News on the RB-030 trial approval (R-Pharm, July 2025).