[E-Daily Reporter Minji Son ] GlaxoSmithKline (GSK) is set to begin full-scale Phase 3 clinical trials for a long-acting antibody called “felcorekibart,” which originated in China. This comes approximately two years after the company acquired a U.S. biotech firm that held the candidate compound. The trend among global big pharma companies to acquire new drug candidates developed in China to expand their late-stage pipelines is spreading to the respiratory disease sector. Analysts note that as Chinese new drugs fill the pipelines of big pharma, the gap with K-Bio is widening further.

According to ClinicalTrials.gov, the U.S. National Institutes of Health (NIH) clinical trial information portal, on the 31st, GSK recently registered six new Phase 3 clinical trials for felcorekibart. These include two trials for chronic obstructive pulmonary disease (COPD), two for asthma, and two for chronic rhinosinusitis with nasal polyps (CRSwNP). The start date for all trials is today (local time), and they are currently in the pre-recruitment phase.

Previously, during its second-quarter earnings announcement last month, GSK announced plans to accelerate clinical development, stating it would increase the number of new Phase 3 trials to be initiated this year from 10 to more than 20. With the registration of these six felcorekibate trials, the company has further solidified its late-stage clinical development plans in the field of respiratory diseases.

The COPD trials, “PERSIST COPD-1” and “PERSIST COPD-2,” will each enroll 624 patients, for a total of 1,248. These trials will compare the incidence of moderate-to-severe exacerbations in patients with severe COPD who experience recurrent exacerbations despite existing inhaled therapy, by adding felcorekivart or a placebo to their current treatment.

The asthma trials, “PERSIST ASTHMA-1” and “PERSIST ASTHMA-2,” will enroll 514 and 370 participants, respectively. These trials target patients whose symptoms remain uncontrolled despite maintenance therapy with medium- to high-dose inhaled corticosteroids (ICS) and long-acting beta-2 agonists (LABA). The studies will evaluate the extent to which asthma exacerbations—severe enough to require systemic steroid treatment, emergency department visits, or hospitalization—are reduced after adding felcorekibate or a placebo to existing treatment over a 52-week period.

A total of 436 participants—218 in each of the two nasal polyps Phase 2 trials—will take part. The trials will evaluate improvements in nasal polyp size and nasal congestion symptoms.

From Jiangsu Hengrui to GSK… Chinese-Developed New Drugs Commanding Higher Prices

Pelcorekibat originated at Jiangsu Hengrui Pharmaceutical in China. Jiangsu Hengrui Pharmaceuticals developed the drug under the code name “SHR-1905” before transferring the development and commercialization rights outside the Greater China region to Aiolos Bio in 2023. Subsequently, GSK acquired Aiolos for $1.4 billion in February 2024, securing the rights.

Felcorekibat is an antibody therapy that blocks “thymic stromal lymphopoietin” (TSLP), a cytokine primarily secreted by airway epithelial cells that triggers inflammatory responses. TSLP activates multiple immune cells simultaneously, causing the inflammatory responses associated with asthma and COPD. Since Felcorekibate blocks TSLP—an early signal—before inflammation spreads, it is expected to be applicable to a broader range of patients than therapies that target only specific inflammatory cells.

Another competitive advantage of pelcorekib is its long dosing interval. Thanks to the application of half-life extension technology and a plasma half-life of approximately 80 days confirmed in Phase 1 clinical trials, GSK is highlighting the potential for administration at intervals of up to six months. Considering that “Tezspire,” an anti-TSLP therapy currently on the market, is administered once a month, the possibility of six-month dosing intervals could differentiate it in terms of convenience.

Follow-on Candidates Also Originate in China… Technology Exports Exceed $130 Billion

The anti-TSLP market already includes “Tezspire” (active ingredient: tezefelumab), jointly developed by AstraZeneca and Amgen. As the first-approved anti-TSLP therapy, it is used to treat conditions such as severe asthma. However, many of the follow-on candidates originate in China. The pattern is for Chinese biotech companies to handle early-stage development, while Western firms secure rights outside the Greater China region and conduct global late-stage clinical trials.

For example, Swiss company Windward Bio’s anti-TSLP antibody “WIN378” was licensed from China’s Kelun Biotech and Harbor BioMed. Utilizing half-life extension technology to achieve a twice-yearly dosing regimen, it is currently undergoing Phase 2 and 3 clinical trials for asthma and Phase 2 trials for COPD.

“BEL512” from U.S.-based Bellenos Biosciences also originated from China’s Kimed. As a long-acting bispecific antibody that simultaneously blocks TSLP and IL-13, it met the primary endpoints in a Phase 2 trial for nasal polyps and is preparing to enter Phase 3 trials for nasal polyps and asthma next year.

In particular, the introduction of BEL512 demonstrates a new approach for Chinese drug candidates to enter overseas markets. This is because global investment firm Obimed established Belenos and acquired rights outside the Greater China region from Kimed. Kimed secured not only an upfront payment and milestones but also a 30.01% stake in Belenos. This is the so-called “NewCo” structure, in which a Chinese company transfers overseas rights to a candidate drug to a newly established entity, and a global venture capital firm covers the subsequent development costs.

A biotech industry official stated, “Since there are already approved products in the anti-TSLP field, it is difficult for latecomers to establish competitiveness,” adding, “Furthermore, because large-scale global clinical trials are required to demonstrate the reduction in asthma and COPD exacerbation rates, the burden on domestic companies is too great to enter this market, which is likely why development has been centered on China.”

Meanwhile, global interest in Chinese drug candidates is not limited to respiratory diseases. According to the National Medical Products Administration (NMPA), the number of overseas technology transfers involving innovative Chinese drugs rose from 94 cases (approximately $51.9 billion) in 2024 to more than 150 cases (approximately $130 billion) last year. The value of contracts in the first half of this year also reached an all-time high of approximately $110 billion. Even considering that this figure includes milestone payments—which are contingent on achieving clinical, regulatory, and sales targets—it is widely recognized that China is rapidly emerging as an R&D hub supplying drug candidates to global pharmaceutical companies.

Consequently, there are calls for domestic pharmaceutical and biotech companies to focus on discovering differentiated candidate compounds and securing early-stage clinical data that would encourage global firms to proceed with late-stage development, rather than chasing highly competitive targets. Another key challenge is establishing transaction structures that allow for the sharing of post-technology-export benefits—such as retaining domestic rights and stakes in newly established subsidiaries while transferring overseas rights.

A biotech industry official stated, “China has established itself as a source of new drugs sought after by global pharmaceutical companies, thanks to government support, a large patient base, and rapid clinical development capabilities,” adding, “South Korea must also focus on technologies and targets where it can be competitive and accumulate data that would encourage global companies to proceed with late-stage development.”