A history of Chinese biotech

How a generics economy became big pharma's primary pipeline

In the first quarter of 2025, China produced 46% of the drugs going into clinical trials and 24% of the first-in-class pipeline. Chinese-originated drugs now make up roughly 30% of the global innovative pipeline, up from a low single-digit share a decade ago. Chinese teams lead the global CAR-T pipeline, with programs going into trials for multiple myeloma, solid tumors like gastric cancer, and refractory autoimmune diseases like lupus.

At the same time, Western pharma has been lagging for decades. As we know, the price of generating every new drug has doubled every decade since the 1950s, with costs now at $2.23 billion/drug and Phase III cycle times growing another 12% in 2024 alone. For roughly one-sixth the R&D spend, China matched the FDA on novel drug approvals in 2024 (48 NMPA first-in-class vs 50 FDA novel) and filed twice as many INDs. Trials run in China cost 50-60% less and Phase I/II non-oncology trials run 60-70% faster than their US equivalents.

The gap is wide enough that 70% of the clinical-stage pipeline now originates outside of big pharma, with a rising percentage of that coming from China. Moreover, top-selling Western drugs are facing loss of exclusivity covering an estimated $200 to $230 billion in annual revenue over the next five years.? Pharma has already spent more than $200 billion on biotech acquisitions since 2019 in attempts to bridge this gap.

It's not that this arbitrage has gone unnoticed. Under the NewCo model, US and UK venture capital forms a Western-domiciled company that licenses a Chinese-developed molecule, brings it under Western regulatory oversight, and sells to big pharma at a Western valuation. The clearest illustration is Aiolos Bio, formed in October 2023 by US investors who paid Hengrui, China's largest innovative pharmaceutical company, $245 million for ex-China rights to an asthma asset. Two months later, GSK acquired Aiolos for up to $1.4 billion. Summit Therapeutics followed the same playbook with even more success, paying Akeso $500 million upfront and committing to $4.5 billion in milestones for ex-China rights to ivonescimab, a PD-1/VEGF bispecific antibody that has since outperformed Merck's Keytruda head-to-head in Chinese non-small cell lung cancer trials. American biotech increasingly works by importing China's cheap infrastructure and stamping on Western credentials.

I’ve compiled the published records of the people, the companies, the political reforms that have shaped the Chinese biotech industry into what it is today. As with many tales, there is no beginning, but perhaps we can begin at rock bottom. Let’s say hello to our friend Mao Zedong.

Contents
  1. 01Great Leaps Forward1949–1978
  2. 02Rebuilding Science After Mao1978–1998
  3. 03Human Genome Project, Chinese CROs, and Science Parks1999–2009
  4. 04Hybridizing with America and Fast-Following Keytruda2010–2014
  5. 05Harmonization and validation2015–2019
  6. 06Public capital for pre-revenue biotech2018–2019
  7. 07Illegal CRISPR Babies2015–2020
  8. 08Losing the COVID RacePending2018–2021
  9. 09Commoditization of the Fast-FollowersPending2021–2024
  10. 10Becoming a Global SupplierPending2022–2025
  11. 11The US Becomes Scared of CCP SpiesPending2024–2026
  12. 12The AI-Bio StackPending2024–2026
  13. 13Patent Cliff and the Licensing FlywheelPending2025–2026

Great Leaps Forward

1949–1978

Mao did not trust science, but he trusted the Russians. When the People's Republic was founded in 1949, the new Chinese Academy of Sciences, was modeled on its Soviet counterpart, inheriting their biology alongside their institutional scaffolding. The most damaging import was the theories of Trofim Lysenko, who had won Stalin’s favor in the 1930s by claiming that acquired traits could be inherited? and that Mendelian genetics was a bourgeois fraud. 

Alternative genetic theories were permitted only after Khrushchev’s “Secret Speech” of February 1956, a closed-door denunciation of Stalin at the 20th Party Congress in Moscow. Chinese geneticists led by Tan Jiazhen, a Caltech-trained Drosophila researcher, used the Qingdao Genetics Symposium that same year to argue publicly for Mendelian inheritance--the first time anyone had done so since the founding of the People’s Republic. 

However, Lysenkoism also extended, far more fatally, into the Chinese agricultural system. In 1958, Mao issued the “Eight-Point Charter of Agriculture,” directly influenced by his doctrines of close-planting and deep ploughing. Such practices contributed to the catastrophic crop failures of the Great Leap Forward and, by extension, the deadliest famine in human history. Estimates range from 15 to 45 million deaths.[7][8]

Miraculously, two major scientific projects still emerged from this period. The first was the total chemical synthesis of bovine insulin. Deciphered by Frederick Sanger, it was the first full protein sequence ever determined, and synthesis was the obvious next frontier. Wang Yinglai began the project in 1958 and saw through its conclusion in 17 September 1965, 8 months before the start of the Cultural Revolution. The accomplishment was nominated for the Nobel multiple times, but Communist policy only recognized collective effort, and the Chinese Academy of Sciences refused to name the contributing scientists. Wang spent the next decade under house arrest in his own institute, attending struggle sessions on Mao Zedong Thought.[9][10]

The second was artemisinin. On 23 May 1967, the People’s Liberation Army launched Project 523, a top-secret military effort to find a treatment for the chloroquine-resistant malaria killing Chinese and Vietnamese troops in the jungles of Southeast Asia. The military framing put the project under the protection of the People's Liberation Army, exempting it from the Cultural Revolution’s wider attack on academic science. Tu Youyou, a 38-year-old researcher at the Academy of Traditional Chinese Medicine trained in both modern pharmacy and classical Chinese pharmacology, was appointed to lead the herbal-medicine team in January 1969. Naturally, her group started by screening candidates from classical Chinese texts and folk medicine, where they found qinghao (青蒿, Artemisia annua, “sweet wormwood”), prescribed in Chinese medicine for intermittent fevers for some 1,500 years. The drug was inconsistently effective against malaria parasites, and Tu ended up identifying the reason why in a 4th-century manuscript. The Jin Dynasty physician and alchemist Ge Hong (284–363), in his Zhouhou Beijifang (Emergency Prescriptions Kept up One’s Sleeve, China’s first emergency manual), had written, “Qinghao, one bunch, take two sheng [2 x 0.2 l] of water for soaking it, wring it out, take the juice, ingest it in its entirety.”[729] From this Tu inferred that her standard heated ethanol-reflux extraction was destroying the drug's active compound. She switched to diethyl ether, which boils at 35°C, and the new extract produced complete inhibition in mouse and monkey models. 

In the absence of clinical trial procedures, Tu and two colleagues dosed themselves to check for toxicity. And seeing no ill effects, they went onto deployed the medicine to 21 more patients in Hainan. The active compound, qinghaosu (青蒿素), earned Tu the Lasker Award in 2011 and the Nobel Prize in Physiology or Medicine in 2015.[11]

Such successes were exceptions in a half-century of state-led attacks on Chinese science. The Cultural Revolution (1966–1976) closed universities to new undergraduates between 1966 and 1969 and to graduate students through 1977; the academy’s budget was slashed to less than one-sixth of its 1965 level by 1967; records document 229 scientists killed or driven to suicide. 

Rebuilding Science After Mao

1978–1998

Mao died in September 1976. In March 1978, with Deng Xiaoping ascendant, the National Science Conference declared the rehabilitation of science and technology a strategic priority.[12]

NSFC annual budget, 1986–2000
02kCNY (millions)198619901993199619982000
NSFC budget
[13]
Approximate, CNY millions. Founded 1986 as China's first peer-reviewed competitive grants agency, the National Natural Science Foundation built the basic-science infrastructure that, alongside the 863 (1986) and 973 (1997) Programs, anchored Deng-era reinvestment in scientific research.

Among the companies that emerged in this period was Hengrui Pharmaceutical, currently the largest Chinese pharma company by market cap. The story behind the company has become somewhat of a Chinese myth and a classic archetype of the time period.

In 1982, Sun Piaoyang graduated from China Pharmaceutical University and joined Lianyungang Pharmaceutical Factory as a technician.[58] He became factory director in 1990. The compounds the factory produced (spiramycin and erythromycin) were "sold for a penny" with no path to profitability without developing new drugs of their own.

He launched the anti-cancer injection VP16 project in 1991, an almost untouched market in China at the time. The factory's profit jumped from ~¥80,000 to over a million.

The following year, in 1992, Sun spent ~¥1.2 million, almost all of the company's profits, on a license to make and sell ifosfamide via a new Chinese-developed synthesis route from the Institute of Pharmaceutical Research of the Chinese Academy of Medical Sciences. He was 34 and newly married, but in his words, "without technology, your fate is in others' hands." It was miraculous that his risks paid off--the factory's revenue exceeded ¥100 million in 1996.[58]

Sun was certainly not a one-trick pony. In 1995 he founded a second pharma company, Hansoh Pharmaceutical, alongside a Hong Kong investor, Cen Junda. Too busy with Hengrui to run the new firm, Sun handed it to his wife Zhong Huijuan, a chemistry teacher at a middle school five minutes by bike from the Lianyungang factory.[210][211] Both companies have become wildly successful, with the couple's combined net worth at roughly $34.7 billion in 2026.[59] Despite their now global reach, they continue to live in Lianyungang, the town where they first met.

Human Genome Project, Chinese CROs, and Science Parks

1999–2009

The Human Genome Project officially began in 1990, an international effort led by the US National Institutes of Health and Department of Energy alongside the UK and France, with Japan and Germany joining later. Chinese genomics infrastructure was sparse at the time. The National Human Genome Center was the only domestic institution focused on the field, and there was no real push to join the international effort until 1997, when a group of four academics newly returned from overseas as the first wave of haigui convinced the Chinese Academy of Sciences to establish a Human Genome Research Center.[18][17]

The new institution compiled a proposal to sequence ~30 megabases on the short arm of chromosome 3. Referred to as the "Beijing Region," it was believed to be linked to esophageal cancer, a disease with extraordinarily high regional incidence in Linxian (Henan) and parts of Sichuan.[18] On September 1, 1999, the proposal was officially approved by the International Genome Sequencing Consortium, making China the only developing country in the project.[60]

Eight days later, on September 9, 1999 at 9:09:09?, Yang Huanming, Wang Jian, Yu Jun, and Liu Siqi formally established Beijing Genomics Institute.[17] Wang Jian would later say of the timing, "这个时间不是我们刻意挑选的，它是天意" ("we didn't deliberately pick this time, it was heaven's will").

Between October 1999 and March 2000, China had to complete 500,000 Sanger sequencing reactions, an effort distributed across 15 teams of the Chinese Human Genome Consortium and centered at BGI's converted building in Beijing's Shunyi District, where ABI 3700 capillary sequencers ran in 24-hour shifts.[18]

Hybridizing with America and Fast-Following Keytruda

2010–2014

Annual returnees from overseas study
01kthousands / year2008201020122014201620182020
returnees
Thousand Talents Program launched late 2008. Annual returnee flow quintupled over the 2008-2014 founding window for BeiGene, Innovent, and Junshi. Series compiled from MoE annual press conferences; intermediate years are MoE-published estimates.

BeiGene was the first company built on the hybrid model, co-founded in 2010 by the American entrepreneur John Oyler and Xiaodong Wang, a Howard Hughes Medical Institute investigator who had left UT Southwestern in 2003 to found and direct NIBS Beijing. Wang's HHMI credential gave the company scientific legitimacy, Oyler's American network let BeiGene raise from US venture firms early, and the company built FDA-grade clinical operations inside China to run global trials at Chinese cost.[19]

Harmonization and validation

2015–2019

The Chinese State Drug Administration was established in 1998 under Zheng Xiaoyu (郑筱萸), reorganized in 2003 as the State Food and Drug Administration with Zheng continuing as director. Over his 7-year tenure (1998 through 2005), Zheng took roughly ¥6.49 million in bribes from eight pharmaceutical and medical-device companies in exchange for personally approving applications, including six drugs later found to be counterfeit. One of them, manufactured by Anhui Huayuan Worldbest Biology Pharmacy, killed 14 patients and left hundreds permanently disabled.[362] Zheng was executed by lethal injection on July 10, 2007, the fourth minister-level state official to face the death penalty in the post-Mao era. In subsequent years, the CFDA underwent significant reform but still struggled with a lack of manpower and proper administrative oversight.

By January 2015, the CFDA was sitting on roughly 22,000 pending applications, mostly low-quality generic and "me-too" filings, with approval timelines stretching past a year. The agency's new director was Bi Jingquan, formerly vice-chair of the National Development and Reform Commission, China's top macroeconomic planning body. He had no expertise in pharma but a track record as a well-oiled bureaucrat with significant political leverage.[21]

Order 117 required companies to self-inspect their clinical trial data, and nearly 80% of the applications were withdrawn. Bi expanded the technical review staff from roughly 120 to over 800,[65] and introduced priority review to fast-track innovative drugs over me-toos.

Pending NDAs at the NMPA
050kapplications20152016201720182019
Pending NDAs
Order 117 (July 2015) directly purged 1,165 of 1,622 pending applications with new clinical data, but the broader 22k → 3.5k collapse came from a combined reform package: CDE reviewer hiring (~70 → >800 staff), priority review, and generic consistency evaluation. Year-end figures are approximate, anchored on the Sept-2015 peak (~22k) and the 2018 endpoint (under 3.5k).

Bi's Marketing Authorization Holder (MAH) system separated drug licenses from the authorization to manufacture them. Before MAH, a license was tied to a specific manufacturing facility, meaning research-heavy biotechs could not hold drug licenses without owning factories. MAH made asset-light biotechs like BeiGene, Innovent, and Junshi structurally possible for the first time.

Under Bi, China joined the International Council for Harmonisation, which made foreign clinical trial data admissible for Chinese registration and aligned Chinese standards with the FDA and EMA. Chinese biotechs could now run trials elsewhere and use the data to file in China, and foreign biotechs could market drugs in China without redoing trials in the Chinese system.

Despite Bi Jingquan's legendary track record and status as the architect of Chinese biotech reform, he was expelled from the Chinese Communist Party on December 9, 2025. The CCDI announcement said he had "accepted gifts, money, trips and banquets and borrowed vehicles from private business owners," "allowed others to pay for him," "secured benefits for others in recruitment," "sought profit for relatives against regulations," and "failed to maintain proper family conduct."[61] His central power had enabled great reform, and inevitably invited the temptations of wealth. It is rare that people with access to both levers do not eventually take the elucidated shortcuts.

Public capital for pre-revenue biotech

2018–2019

Charles Li Xiaojia (李小加) was born in Beijing in 1961. His teenage years coincided with the Cultural Revolution and he avoided being sent to the countryside by taking a work assignment on an offshore oil rig in the Bohai Sea. When the universities reopened, he studied English literature at Xiamen University, graduating in 1984, and took his first professional job as an editor-reporter at China Daily, the Party's English-language newspaper. A scholarship, won on the back of a piece about corruption in Chinese soccer, took him to the United States, where he applied for schools in alphabetical order and took an offer at the University of Alabama. Columbia Law School followed in 1991, then fifteen years on Wall Street as the primary point of contact for a wave of Chinese SOE listings abroad, including China Mobile, PetroChina, Sinopec, and the big-four banks.[62]

In June 2009 he was named CEO of Hong Kong Exchanges and Clearing, the first mainland-born executive to lead the institution. He took office in January 2010 and stayed eleven years.

The defining accomplishment was infrastructure. The Shanghai-Hong Kong Stock Connect in November 2014 created, for the first time, a regulated channel through which mainland Chinese investors could buy Hong Kong stocks and global investors could buy Shanghai-listed A-shares. Shenzhen-HK Connect followed in 2016, Bond Connect in 2017. The new capital channels turned Hong Kong into the world's number-one IPO venue in seven of his eleven years.

In 2013, Alibaba was preparing the largest IPO in history and wanted to list in Hong Kong. The structure they proposed was unusual. Alibaba's shares would be one-share-one-vote on paper, but board nominations would be controlled exclusively by the Alibaba Partnership, a 28-person internal group dominated by Jack Ma and Joe Tsai that could renominate its own candidates indefinitely if shareholders voted them down.

HKEX rules at the time prohibited it. Hong Kong had banned dual-class share structures in 1989 after two decades of family-controlled conglomerates abusing them at minority shareholders' expense, and the regulatory establishment, particularly the independent Securities and Futures Commission, held that one-share-one-vote was a foundational element of Hong Kong's investor-protection regime. Through 2013, HKEX and Alibaba tried to find a workaround.

On October 24, 2013, Li published a piece on the HKEX corporate blog titled "Taking the Debate Forward: Should Hong Kong Act on Non-Standard Shareholding Structures?" He framed the entire piece as a dream in which nine archetypal characters, Mr. Tradition, Mr. Innovation, Mr. Disclosure, Mr. Big Fund, Ms. Small Retail, Ms. Pragmatic, Mr. Morality, Ms. Future, and Mr. Procedure, visit him in his sleep and argue with each other about whether Hong Kong should accommodate new-economy companies with non-traditional governance. Li does not take sides, but he does clearly acknowledge the stakes, famously writing that "losing one or two listing candidates is not a big deal for Hong Kong; but losing a generation of companies from China's new economy is." He could not, as the sitting CEO of a public exchange, advocate for reversing a 24-year-old investor-protection rule on the strength of one IPO; the blog post illustrated the complexity of his position.

By month's end, Alibaba had given up on Hong Kong. On September 19, 2014, they listed on the NYSE. Priced at $68, opened at $92.70, raised $25 billion, the largest IPO in history. The secondary trading volume, which HKEX could have monetized, has run in the billions of dollars per day for the decade since. All of it went to New York.[63]

Li spent the next four years rebuilding the political coalition for change, this time with the Alibaba precedent as evidence. The package finally landed in April 2018 as Chapter 8A, allowing weighted voting rights for innovative companies; Chapter 18A, allowing pre-revenue biotech listings; and Chapter 19C, allowing secondary listings for Greater China companies already public in the US or UK. Chapter 19C was specifically designed as the path for Alibaba to return to Hong Kong. In November 2019, five years and two months after the NYSE listing, Alibaba executed a secondary listing on HKEX, raising $11.2 billion.[28]

Cumulative pre-revenue biotech listings, HKEX 18A vs STAR Market
0100listings201720182019202020212022202320242025
HKEX 18ASTAR Market
[711]
HKEX Chapter 18A launched April 2018; STAR Market launched July 2019. The 75+ / $30B endpoint for 18A is documented; STAR series approximate.

In the same window as Bi Jingquan's CFDA reforms, MAH (2015) and ICH membership (June 2017), Chapter 18A gave Chinese biotechs a public-market venue. BeiGene's Hong Kong secondary listing in August 2018 was the proof of concept. By end-2021, 48 biotechs had listed via 18A, raising about US$14 billion;[64] by late 2025, more than 75 had raised over $30 billion. Regulatory reform in Beijing increased supply, and the listing reform in Hong Kong provided the venue for valuation.

Illegal CRISPR Babies

2015–2020

China's debut on the global pharma stage not without scandal. In April 2015, Junjiu Huang at Sun Yat-sen University published the first report of CRISPR-mediated gene editing? in human zygotes (non-viable tripronuclear embryos), an attempt to correct a β-globin mutation that causes thalassemia. The paper had been rejected by Nature and Science on ethical grounds before appearing in Protein & Cell,[23] and within weeks the International Summit on Human Gene Editing concluded that clinical use of germline editing would be “irresponsible.”[24] The following year, Chinese researchers conducted the first reported human trial using CRISPR-edited cells.

On 25–26 November 2018, on the eve of the Second International Summit on Human Genome Editing in Hong Kong, the Shenzhen-based biophysicist He Jiankui announced the birth of twin girls whose CCR5 gene, the immune-cell receptor that HIV uses to enter T cells, had been edited at the single-cell stage to confer HIV resistance. Not only was the editing technically sloppy (the twins were genetic mosaics with off-target effects), the ethical-review documents were discovered to have been forged.[31]

The case closed in December 2019 with a three-year prison sentence for “illegal medical practice.”[35] Beijing then pushed through a substantive legal overhaul: the 2019 Regulations on Human Genetic Resources, the 2020 Civil Code and Biosafety Law, and the 2020 eleventh amendment to the Criminal Law (which criminalized illegal human gene editing with up to seven years’ imprisonment).[36][37]

Since leaving prison, He Jiankui has been offered a position at a state-sponsored medical academy in Shenzhen. He remains occasionally active on X, where he tallies his funding (currently at $25,073 from 715 private donors) and invites his followers to nightclubs in Beijing. His current 10-year plan includes receiving the Nobel prize in 2029 and being canonized as a Roman Catholic saint in 2030.

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