Home Phase III Trial Imminent: AI-Driven Biopharma Enters the Eve of Commercialization

Phase III Trial Imminent: AI-Driven Biopharma Enters the Eve of Commercialization

Jun 26, 2026 16:49 CST Updated 16:49
ANTENGENE CORPORATION

Innovative Oncology Drug Developer

XtalPi

Computation-Driven Innovative Drug R&D Provider

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Recently,Insilico MedicineANTENGENE CORPORATION,XtalPiSeparately Announced Major Progress: Insilico Medicine is About to Launch the Phase III Clinical Trial of the World's First AI-Developed Innovative Drug and Has Reached the Largest BD Cooperation in the Asia-Pacific Region with SK Biopharmaceuticals; Antengene Corporation Successfully Exported Its TCE Products Through an Innovative "NewCo" Model;XtalPi Secures Over $400 Million in AI Drug Discovery Collaboration with Internationally Renowned Pharmaceutical Company

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The World’s First AI-Developed Innovative Drug Enters Phase III Clinical Trials

If AI-driven target discovery and molecular design are akin to exploring “no man’s land,” thenInsilico MedicineRentosertib (ISM001-055), an oral medication for the treatment of idiopathic pulmonary fibrosis, has entered Phase III clinical trials, marking it as the first milestone achieved by humanity in the field of AI-driven biopharmaceuticals.


Preclinical Studies of Rentosertib Completed in Zhangjiang Pharma Valley, itsIt took only 18 months and cost approximately $2.6 million to go from target discovery to the nomination of a preclinical candidate compound. Without AI intervention, the traditional R&D process would typically require 4–5 years and cost at least hundreds of millions of dollars.


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(Image source: Shangguan News, Jiefang Daily)


Nature Medicine's major announcement also validates the potential value of Rentosertib.In June 2025, Rentosertib achieved positive results in the GENSIS-IPF Phase IIa clinical trial, marking the first global proof-of-concept for the efficacy of AI-driven drug discovery, and was published inNature Medicine


More importantly, Rentosertib is not an isolated case but a systematic output.Insilico Medicine is redefining the efficiency of preclinical drug development and setting new standards through its advanced AI and automation platform. While traditional early-stage drug discovery typically takes 2.5 to 4 years, Insilico Medicine advances projects from initiation to the nomination of preclinical candidate compounds in an average of just 12 to 18 months, requiring the synthesis and testing of only 60 to 200 molecules per project. Since 2021, the company has nominated 31 preclinical candidate compounds, 13 of which have received Investigational New Drug (IND) approval.


The lead investigator for this Phase III clinical trial of Rentosertib is Professor Xu Zuojun from Peking Union Medical College Hospital, with co-lead investigators being Academician Zhong Nanshan of the Chinese Academy of Engineering and Chen Chang, Director of Shanghai Pulmonary Hospital. Over one hundred researchers from 35 clinical centers gathered in Beijing, underscoring the high expectations within the medical community for this drug.


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Diversified BD Models: Launching the NewCo 2.0 Paradigm

Today, AI-driven drug discovery has moved beyond “proof of concept” to a stage of “dual realization of clinical and commercial value.”


Shortly after the official announcement of the initiation of Phase III clinical trials for Rentosertib,Insilico Medicinewith SK BiopharmSecured transactions totaling over $2.5 billion. Under the agreement, Insilico Medicine will receive an upfront payment and near-term milestone payments of up to $18 million, followed by additional milestones covering development, regulatory approval, and commercialization, as well as single-digit percentage royalties on net sales post-commercialization.


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Pharma.AI Platform

(Image source: Shangguan News, Jiefang Daily)


This marks Insilico Medicine’s largest collaboration to date with a partner in the Asia-Pacific region, with strategic significance extending far beyond financial metrics. Leveraging its Pharma.AI platform, Insilico Medicine is responsible for discovering, designing, and optimizing novel drug candidates for neuroimmunology indications, while SK Biopharm leads late-stage development and commercialization. This represents a deep collaborative model that leverages each party’s core strengths and shares risks.


This collaboration also marks the second deal of similar scale that Insilico Medicine has secured with a major pharmaceutical company. In late March this year, Insilico Medicine announced that it had signed a $2.75 billion agreement with U.S. pharmaceutical giant Eli Lilly to develop a novel oral therapeutic candidate, currently in the preclinical development stage, with potential “best-in-class” status.


If Insilico Medicine represents the "technology-driven" global expansion of AI drug discovery, then Antengene Corporation demonstrates a model innovation characterized by the "dance of capital and assets."


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(Image source: screenshot from the Pudong TIME WeChat Channel)


June 22,ANTENGENE CORPORATIONAnnounced two collaboration agreements with K2 Therapeutics, a portfolio company of MPM BioImpact, granting exclusive global rights (excluding Greater China) to ATG-106 (CDH6-CD3), a first-in-class pipeline for solid tumors, while simultaneously securing an option for collaboration on a second preclinical TCE pipeline.


The industry views this collaboration model as providing a novel demonstration sample for the global layout of domestic innovative drug enterprises: breaking away from the rigid framework of single-asset licensing in the industry, leveraging the comprehensive clinical and capital networks of international venture capital firms to create a NewCo 2.0 paradigm characterized by dual-pipeline synergy, deep equity binding, and front-loaded empowerment with global resources.


Unlike the limitations of the first-generation NewCo model, which was confined to isolated single-asset transactions, this collaboration innovatively adopts a dual-pipeline bundled structure. It establishes an independent asset company for Antengene Corporation’s self-developed solid tumor pipeline while securing an option for a second preclinical pipeline, thereby building a sustainable global expansion framework capable of housing multiple assets on a single platform and addressing the core deficiency of previous models, namely the lack of follow-on pipeline synergy.


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(Image source: XtalPi)


XtalPiVarious business development (BD) collaboration models have also been developed, such as deeply linking near-term R&D revenue with the long-term value of pipeline assets. This approach not only effectively reduces the costs and risks for XtalPi in participating in the R&D of high-barrier targets but also secures the high-upside return potential of blockbuster drugs.


On June 10, XtalPi announced a strategic AI drug discovery collaboration with a renowned international biopharmaceutical company, valued at over $400 million. The two parties will jointly develop innovative oral small-molecule drugs with “Best-in-Class” potential, targeting a GPCR (G protein-coupled receptor).


Under the agreement, the partner will pay XtalPi an upfront fee and bear all early-stage R&D costs. XtalPi will also receive milestone payments for preclinical, clinical, and commercialization stages, as well as future sales royalties, with the total potential value of the project exceeding $400 million.


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Empowering Ecosystems: Helping AI-Driven Pharmaceutical Companies Connect Globally

Amid the AI-driven wave in pharmaceuticals, Zhangjiang in Pudong has quietly emerged as the epicenter and frontrunner of this transformation, leveraging its deep industrial foundations and forward-looking strategic layout.


Dr. Alex Zhavoronkov, Founder and CEO of Insilico Medicine, was deeply impressed by this. “Zhangjiang Pharma Valley has such a large number of CROs (Contract Research Organizations), as well as abundant talent and a vibrant, hardworking community where people are dedicated to delivering experimental results rapidly with the highest quality. This is why we chose to establish our presence in Shanghai.”


Today, Insilico Medicine is experiencing rapid growth by leveraging its self-developed Pharma.AI platform and the new drug R&D ecosystem in Zhangjiang Science City. Listed on the Hong Kong Stock Exchange at the end of 2025, it became China’s first “AI-driven pharmaceutical company” to go public.


ANTENGENE CORPORATION also established an early presence in Zhangjiang.In 2020, the companyEstablishing an R&D center in Zhangjiang, leveraging the well-developed CRO industry chain for early-stage research and development in Zhangjiang and the advantages of the regional biopharmaceutical talent cluster.ANTENGENE CORPORATIONSteadily advance cutting-edge molecular discovery and platform technology iteration.


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AnTenGager® Mechanism

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In the past few years, leveraging the founding team’s extensive experience in global oncology clinical development, Antengene Corporation has keenly identified TCE as a golden track for next-generation immunotherapy,At Zhangjiang, we independently developed and built the second-generation AnTenGager differentiated TCE platform, directly addressing the industry pain points of insufficient efficacy and high incidence of cytokine storm associated with the first-generation TCE, thereby forming a comprehensive, fully self-developed pipeline matrix covering both solid tumors and autoimmune diseases.


Currently, artificial intelligence is integrating into the entire drug R&D chain with unprecedented depth and breadth, injecting intelligent acceleration into innovative drug development and paving new paths for leapfrog industrial growth. Through multi-dimensional measures—including policy support, ecosystem building, resource assurance, scenario empowerment, and institutional innovation—Pudong is providing comprehensive assistance to the AI-driven pharmaceutical industry, propelling the biomedical sector toward a new stage of high-quality development.

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Compiled from: Shangguan News, Pudong Release, official WeChat accounts of various companies, etc.

Cover image generated by AI