{"id":7435,"date":"2026-06-30T15:02:51","date_gmt":"2026-06-30T21:02:51","guid":{"rendered":"https:\/\/allphasepharma.com\/dir\/?p=7435"},"modified":"2026-06-30T20:49:00","modified_gmt":"2026-07-01T02:49:00","slug":"drug-development-in-china-moving-beyond-the-me-too-path","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2026\/06\/30\/7435\/drug-development-in-china-moving-beyond-the-me-too-path\/","title":{"rendered":"DRUG DEVELOPMENT IN CHINA \u2013 Moving Beyond the Me-Too Path"},"content":{"rendered":"
\n
\"\"<\/a><\/figure>\n<\/div>\n\n\n

We have to thank Liu and colleagues for a thorough review of pharmaceutical development activities in China and elsewhere during the last decade.<\/a>[1]<\/a>  The authors reviewed a total of 34,844 Phase 1-3 trials, showing a significant uptick in studies initiated by Chinese companies.  Compared to 2015, trial numbers have steadily increased worldwide; as can be seen in Figure 1, this increase came disproportionally from China.<\/p>\n\n\n

\n
\"\"<\/a>
Figure 1: Trials in Clin Dev China vs Global 2015-2025.  Modified from Ref. [1]<\/a><\/figcaption><\/figure>\n<\/div>\n\n\n

The authors also looked at specifics, the stage of research and the focus of innovation that occurred in China. <\/p>\n\n\n\n

Not surprisingly, most trials in China are Phase 1 trials; at this early stage, foreign companies make good use of China\u2019s CRO capacities.  The decision to outsource is always made based on quality, cost, and regulatory considerations at a particular site that could impact study start-up.  With quality much better than in former years and a more flexible regulatory mindset, China has become an attractive place to conduct clinical research.  However, in a competitive world, with everything else being equal, costs are a major decision criterium, even for Phase 1.  While the price of studies, ie, per patient cost, is still lower in China than in most other regions, the gap favoring Chinese sites is diminishing.  In our estimate, clinical services in China no longer come at a bargain price. <\/p>\n\n\n\n

So long as there still is a cost differential, it will attract Big Pharma.  No wonder Australia ranks high for Phase 1 work with their low costs.  Even Chinese companies like to start their programs in Australia as it offers tax incentives and efficient regulatory review. <\/p>\n\n\n\n

The reverse is true for Phase 3 studies which are still mainly conducted outside of China in countries targeted for future marketing.  This is clearly borne out by the Liu data analysis.  Rarely do Chinese companies venture abroad; most of their programs stay in China, especially early-on. Hence, Phase 3 trials in China are conducted with China as a participant, not as the main contributor, in most cases.<\/p>\n\n\n\n

This will eventually change.  It makes economic sense for China and other SEA countries to take on a leadership role especially when diseases are more prevalent in that part of the world.  Consider IgAN, a disease more common in Asia.  With several compounds vying for patients to enroll in Phase 3 trials, it would seem foolish to skip Chinese centers.  Likewise, MDR acinetobacter infections are much more rare in the West than in the East; therefore, it is imperative to involve high-prevalence areas like China for Phase 3.<\/p>\n\n\n\n

Like most R&D worldwide, clinical trials in China are dominated by oncology compounds coming from well-established target areas: PD-1, BTK, JAK, EGF, etc.  There is a big push into mAbs, bispecifics and ADCs.  Liu calls it a \u2018fast-follower mentality\u2019, an assessment that accurately reflects the past 10 years.<\/p>\n\n\n\n

This is bound to change in the next decade.  We believe that research leadership will translate into more innovation coming from within China, gradually driving clinical programs away from established targets towards greater innovation.  The research output and excellence of top universities in Shanghai (Fudan) and Beijing (Tsinghua) is nothing short of extraordinary; these institutions and others in China will spearhead a pipeline of new drug candidates to be tested and validated with or without foreign help. <\/p>\n\n\n\n

As we mentioned in a prior blog, the China market for pharmaceuticals is still held hostage by the lack of investments of the magnitude required at later stages of clinical development.[8]<\/a>  The China market is also more controlled than most foreign investors realize.  We know of several examples of drugs that are blockbusters in the US, EU and Japan but barely profitable in China after passing NRDL cost controls. <\/p>\n\n\n\n

For now, this relegates Chinese research output to a supplier function for pharmaceutical companies that have a need to bolster their dwindling pipeline, face a patent cliff, or encounter market pressures from generics and regulatory price erosion. <\/p>\n\n\n\n

As long as the China market for novel pharmaceuticals does not create conditions for profitability of its own industry and within its own borders, we have an export-oriented research-based industry there.  Hence, unless this situation changes in the future, China\u2019s pharmas will have to provide drug candidates primarily to the outside world, supporting their portfolio mainly with royalties and partnerships with Big Pharma.  This is what most Chinese start-ups are striving to achieve, with few exceptions. <\/p>\n\n\n\n

Revenues for Brukinsa, BeiGene \/ BeOne\u2019s flagship BTK inhibitor are 75% US-based [2]<\/a>, and those for Vyvgart, the FcRn inhibitor from Argenx, are approx. 10x higher than in China.<\/p>\n\n\n

\n
\"\"<\/a>
Figure 2: Brukinsa Sales. Modified from Ref. [2]<\/a><\/figcaption><\/figure>\n<\/div>\n\n\n

The list price for Legend Biotech\u2019s Carvykti, a BCMA-directed CAR-T injectable for refractory MM is $465k-$593k in the US [3]<\/a>.  It is currently the most expensive drug that money can buy.  The NRDL price in China is $80k-140k but may be as low as $55k [7]<\/a> .  For Europe we find a range of prices, all higher than in China, with the notable exception of Turkey [3]<\/a>,[4]<\/a>,[5]<\/a>,[7]<\/a>:<\/p>\n\n\n\n