How China’s regulatory reforms are reshaping global clinical trials and partnerships 

Author: Jeff Southwood

A combination of regulatory reforms and research funding and investment in China has created a situation where a group of Chinese companies have full pipelines, but need partners to market those drugs beyond Greater China. AdisInsight’s recent report, Strategic Pharma Insights: Asia Focus Part I: China’s Movers and Shakers, details 10 of these companies and their pipelines, but I wanted to take a more holistic view of how this is playing out, by looking at the forces driving this, some key pipeline highlights, and the opportunities for global pharma companies  

Why regulatory reform matters 

How would a country like China transform its pharmaceutical sector from a generics-manufacturing “back office” mainstay to an innovation powerhouse? China’s investments in basic research, of course, are one necessary but not sufficient place to start. The next step would be: Streamline and reform clinical trial and approval/licensing processes.   

So, starting in 2015, and continuing in 2020, China took active steps to reform its regulatory and clinical trials processes, making them, at a minimum, competitive with the rest of the world (if not even more efficient). In 2015, China instituted its “Opinions on the Reform of Review and Approval Process for Drugs and Medical Devices,” and took a further step in 2020 with the revision of the “Provisions for Drug Registration.” These introduced expedited pathways for priority review, conditional approvals, and breakthrough therapy designations, and shortened development timelines and reduced regulatory bottlenecks.   

These reforms particularly stimulated development of drugs using newer technologies like monoclonal and bispecific antibodies, chimeric antigen receptor T-cell (CAR-T) approaches, and others, that are showing great promise in dealing with previously intransigent diseases (pancreatic cancer, for example). Moreover, these reforms have given investors increased confidence in China-developed therapies, helping these companies attract and develop global partnerships.  

And while China’s rapidly evolving biotech and pharma sector is having great success with therapeutics, many of these companies lack the global marketing footprint needed to bring these new drugs to the patients around the world who need them. This combination means opportunities for global and US/EU-based companies to partner with Chinese firms to bring these badly needed medicines to the world.   

Combined with investments in research, and in companies commercialising that research, China is now home to a collection of biotech and pharmaceutical companies with portfolios of approved or late-stage therapies for treating life threatening diseases.   

The report, Strategic Pharma Insights: Asia Focus Part I: China’s Movers & Shakers, looks at 10 of these firms, highlighting key compounds in their portfolios, along with these companies’ strengths, weaknesses, and opportunities for global pharmaceutical companies. The report profiles the following companies: Akeso, 3SBio, Insilico Medicine, Sinopharm, Innovent Biologics, Legend Biotech, WuXi Biologic, Duality Biologics, Sciwind Biosciences, and Lepu Pharma.

Reform’s results: Drugs in late trials or recently approved 

Many of the therapeutics in late development or on the market come from advanced biotech categories, especially breakthrough therapies or expedited review. These include monoclonal and bispecific antibodies or other biologics treating cancer, metabolic disorders, or autoimmune disorders — some of the most difficult disease states to treat.

For example, Akeso’s lung cancer bispecific antibody, Ivonescimab, outperformed Merck’s Keytruda for non-small cell lung cancer (NSCLC), giving patients more than 11 months without progression, as compared to Keytruda’s 5.8 months. But Keytruda’s first-mover advantage combined with Merck’s global marketing footprint has kept Keytruda as the market leader, despite Ivonescimab better efficacy.

Another example: Sinopharm Group’s Anlotinib, already approved for nine cancer indications, with three more under review. Sinopharm Group’s explosive growth — moving to the 4th strongest pharmaceutical company (up from 13th) on the strength of its herpes zoster mRNA vaccine, a joint venture with Lonza, and its pivotal role in global COVID-19 vaccine development.

Innovent Biologics has both a GLP-1 compound (mazdutide) already approved, as well as its foothold in oncology with sintillmab.

Quick bullet points of other key developments include:

• 3SBio has signed a landmark licensing deal (up to $6B) with Pfizer for SSGJ‑707 (PD‑1/VEGF bispecific), granting global rights outside China and setting up planned Phase III programs internationally.   
• Insilico Medicine is pioneering AI‑driven drug discovery that is boosting R&D productivity and feeding assets into global development; the references include recent financing that underpins these programs.   
• Innovent Biologics has secured China approval for Sycume (teprotumumab biosimilar) in thyroid eye disease; expanded internationally via Roche collaborations and a $1.2B Takeda agreement covering late‑stage oncology assets outside Greater China.   
• Legend Biotech is advancing innovative CAR-T programs with strategic collaborations (e.g., Janssen, Novartis), drawing strong global investor attention.   
• WuXi Biologics achieved EMA approval at its Dundalk, Ireland site enabling first commercial launch there, and passed FDA pre‑license inspections across multiple Wuxi facilities—strengthening global dual‑sourcing and trial support.   
• Duality Biologics (DualityBio) reported Phase III success (with BioNTech’s BNT323) in HER2‑positive breast cancer and licensing (DB‑1418) alongside a successful Hong Kong IPO—evidence of late‑stage momentum with antibody-drug conjugates (ADCs).   
• Sciwind Biosciences has signed a $70M upfront global licensing (outside China & South Korea) with Verdiva Bio for ecnoglutide and amylin receptor agonists, with up to $2.4B in milestones—positioning metabolic assets for wider trials.   
• Lepu Biopharma is advancing an ADC pipeline with a major licensing deal for MRG007 and presented preclinical data at AACR 2025; also out‑licensed TOPAbody T‑cell engager assets to Excalipoint with significant milestone potential.

Local changes, global effects 

The company profiles in this report suggest a few key takeaways for global R&D managers. Some of these include the fact that for research originating in China, oncology and metabolic diseases are a near-term sweet spot, including anti-cancer monoclonal and bispecific antibodies, and synthetic hormones (including GLP-1s) for metabolic diseases. Also, AI-born pipelines and non-traditional drug discovery are growing in China, with companies like Insilico. And global companies should anticipate rapid expansion beyond China, by way of China-global partnerships.

Key takeaways for global R&D teams 

The company profiles in this report suggest a few key takeaways for global R&D managers. Some of these include the fact that for research originating in China, oncology and metabolic diseases are a near-term sweet spot, including anti-cancer monoclonal and bispecific antibodies, and synthetic hormones (including GLP-1s) for metabolic diseases. Also, AI-born pipelines and non-traditional drug discovery are growing in China, with companies like Insilico. And global companies should anticipate rapid expansion beyond China, by way of China-global partnerships.  

You can see more — and in more depth — in the report, Strategic Pharma Insights: Asia Focus Part I: China’s Movers & Shakers.

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