[China Shock, K-Industry on the Brink | Biotech] ③ Chinese Drug Sold for $8.4 Billion: The Results Three Years Later

Tracking Nine Chinese Drug Candidates Licensed Out
Six Candidates Show Results in Phase III Trials
ADC Cancer Drugs Confirmed to Improve Survival

Editor's NoteAs China's industrial rise rapidly expands into new areas, its growing influence in the biotech sector is becoming increasingly apparent. In particular, China has consistently achieved unprecedented or highly exceptional results in recent years in technology deals involving drug candidates with global Big Pharma companies, readily overtaking competitors, including South Korea. This series examines the source of China's strength and how South Korea, which once led China by building a strong reputation across global industries, should respond going forward.

① Big Pharma Sweeps Up Chinese Drug Candidates

② Difficult to Sell Even Once, but China Sells Again and Again

③ Chinese Drug Candidate Sold for $8.4 Billion: Results Three Years Later

④ Can South Korea Weather the Endurance Test of Late-Stage Development?

China's "biotech rise" is making an impact on the global stage with a steady stream of major achievements. An analysis of follow-up research and development (R&D) on drug candidates licensed out by Chinese companies shows just how pronounced this trend has become. Many of the major licensed-out candidates that drew attention across the domestic and global biotech industries have advanced to Phase 3 trials or beyond, bringing them close to commercialization.

The Asia Business Daily analyzed on October 19 eight Chinese-origin licensing deals from 2023, each worth at least $1 billion, for which the assets, deal value, and actual transfer of licensing rights could be verified. A total of nine drug candidates were transferred to global Big Pharma companies through these deals. Of these, six reached Phase 3 trials or achieved meaningful results in Phase 3 within a relatively short period of around two years.

A prominent example is BL-B01D1, an antibody-drug conjugate (ADC) that U.S.-based Bristol Myers Squibb (BMS) licensed from China's SystImmune. The deal was signed in December 2023 for up to $8.4 billion (approximately 11.2392 trillion won), including an upfront payment of $800 million (approximately 1.0704 trillion won). The candidate met its primary endpoints in all three Phase 3 trials conducted in China. This past June, it significantly improved progression-free survival (PFS) and overall survival (OS) in separate Phase 3 trials for triple-negative breast cancer and esophageal cancer, respectively.

Other major deals are also progressing into late-stage development. CMG901, a CLDN18.2 ADC licensed by AstraZeneca from KYM Biosciences for up to $1.188 billion (approximately 1.5895 trillion won), has advanced from Phase 1 to Phase 3. This past July, it was found to have significantly extended overall survival in a Phase 3 trial for gastric and gastroesophageal junction cancers. DB-1303 and DB-1311, ADCs licensed by BioNTech from DualityBio, are also in Phase 3 trials for breast and endometrial cancers, and prostate cancer, respectively.

HS-20093, a B7-H3 ADC licensed by Hansoh Pharmaceutical to GSK, improved overall survival in a Phase 3 trial for small-cell lung cancer in China this past July, and a marketing authorization application was accepted in September. HS-20089, a B7-H4 ADC, also entered Phase 3 trials for ovarian and endometrial cancers this year. ECC5004, an oral glucagon-like peptide-1 (GLP-1) candidate licensed by AstraZeneca from China's Eccogene, has completed Phase 2b and is preparing for Phase 3. In a trial of patients with obesity this year, it demonstrated weight loss of up to 11.8% at 36 weeks.

Not only are individual candidates advancing, but cases of Chinese drugs being validated in late-stage development are also increasing. According to the Boston Consulting Group (BCG), the number of Chinese-origin Phase 3 "head-to-head" trials using patented global medicines as comparators rose from none in 2020 to four in 2023, nine in 2024, and six last year. The number of innovative drugs developed in China and approved by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA) also increased from two in 2020 to six in 2024. The analysis indicates that Chinese drugs are building a track record of success in late-stage trials and the regulatory approval process, rather than stopping at licensing deals.

Not all major deals have succeeded. Ocedurenone, a hypertension treatment acquired by Novo Nordisk from KBP Biosciences in 2023 for up to $1.3 billion (approximately 1.7394 trillion won), failed to meet the efficacy criteria in an interim analysis of a Phase 3 trial the following year, and development was discontinued. Further development of HRS-1167, a PARP1 inhibitor licensed by Hengrui Pharma to Germany's Merck KGaA, also stopped after early-stage trials. Of the nine candidates, seven continued into late-stage development, while two were dropped from global pharmaceutical companies' development portfolios.

An industry official said, "A licensing deal is only the first assessment of a drug candidate. What matters is how far the partner company has advanced development of the candidate several years after the technology transfer was announced, rather than the total deal value at the time. Reaching a global Phase 3 trial means the candidate survived the company's internal development-priority assessment and was deemed worthy of continued investment."

This content was produced with the assistance of AI translation services.