{"id":4269,"date":"2026-10-12T08:32:28","date_gmt":"2026-10-12T08:32:28","guid":{"rendered":"https:\/\/nhdbio.com\/?p=4269"},"modified":"2026-10-12T08:32:28","modified_gmt":"2026-10-12T08:32:28","slug":"hrs1596-wochentlich-orales-glp1-gip-lizenz","status":"publish","type":"post","link":"https:\/\/nhdbio.com\/de\/hrs1596-weekly-oral-glp1-gip-license\/","title":{"rendered":"Einmal w\u00f6chentlich orales GLP-1\/GIP: Wo steht HRS-1596?"},"content":{"rendered":"
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Editorial illustration, not an experimental photograph.<\/figcaption><\/figure>\n

If it only needs to be taken orally once a week, long-term treatment could be more convenient. The collaboration news about HRS-1596 has drawn attention to this direction. However, a development concept, entering a phase one trial, and having been proven effective are three different things.<\/p>\n

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First, look at what actually happened this time<\/h2>\n

On September 29, Novo Nordisk and Hengrui announced an exclusive licensing agreement for HRS-1596. The licensed territory is outside mainland China, Hong Kong, Macau, and Taiwan.<\/p>\n

This is a research and development and business collaboration, not a marketing approval announcement. Public materials state that HRS-1596 is ready to enter phase one and has already been approved in China to conduct a phase one clinical trial for weight management and type 2 diabetes.<\/p>\n<\/section>\n

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Dual receptors can be understood as two signaling entry points<\/h2>\n

GLP-1 and GIP are signals involved in metabolic regulation. A so-called dual receptor agonist is intended to act on these two types of receptors with one candidate molecule.[1]<\/a><\/p>\n

Receptors can be thought of as entry points through which cells receive signals. The same entry point does not mean the same molecule; binding strength, residence time, and route of administration can all differ. Therefore, HRS-1596 cannot be directly called "oral tirzepatide."<\/p>\n<\/section>\n

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The difficulty of once-weekly oral dosing is not only in making a tablet<\/h2>\n

To give a dose once a week, there needs to be sufficiently durable exposure and effect; to enter the body through the mouth, absorption and stability also need to be addressed. Both requirements must be met at the same time.[1]<\/a><\/p>\n

The collaboration announcement describes the development potential of once-weekly oral dosing. It did not publish clinical results sufficient to judge long-term weight loss magnitude, so it is not yet possible to estimate how many kilograms could be lost or whether it is better than existing drugs.<\/p>\n<\/section>\n

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US$2.6 billion, why can it not be treated as already paid?<\/h2>\n

The announcement lists an upfront payment of US$300 million, with a potential total amount of up to US$2.6 billion. The later amounts are related to research and development, regulatory, and commercial milestones, and may only be paid after the corresponding conditions are met; sales royalties are also involved.<\/p>\n

This shows that the partner is willing to invest resources, and it also shows that there are still many steps that need to be completed afterward. The transaction amount itself is not proof of drug efficacy.<\/p>\n<\/section>\n

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What news is worth waiting for next?<\/h2>\n

Phase one first needs to understand safety, tolerability, and drug exposure in humans, and then see whether preliminary efficacy signals appear. Larger-scale and longer-term studies are suitable for answering long-term changes in weight and blood glucose.<\/p>\n

If follow-up news only says "first participant dosed" or "reached a certain exposure level," it is still different from completing a weight-loss efficacy trial. Reading by research and development stage is more useful than chasing one big number.<\/p>\n<\/section>\n

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If the receptors are the same, why still run clinical trials again?<\/h2>\n

Receptors are only one part of the effect. How much of the molecule enters the body, how long it lasts, and what additional effects it produces may all differ, so data from existing drugs in the same class cannot complete validation for a new molecule.<\/p>\n

Phase one news should focus on safety and human exposure. Follow-up efficacy studies should continue to look at population, observation time, controls, and discontinuation and adverse reactions. News from different stages should not be interpreted with the same standard.<\/p>\n<\/section>\n