Clinical Data at ERS Conference: Estimating the Value of MABWELL's 9MW1911

Deep News
09/11

Recently, MABWELL-B presented data from its Ib/IIa clinical study of 9MW1911 in moderate-to-severe COPD patients with a prior smoking history at the 2026 European Respiratory Society (ERS) annual meeting in a poster session. As the core asset in MABWELL's respiratory disease pipeline, the clinical progress and commercial potential of the highly selective anti-ST2 monoclonal antibody 9MW1911 have been a key focus for capital markets. We have calculated the intrinsic value of the pipeline based on the industry-standard risk-adjusted net present value (rNPV) model, combined with publicly available clinical data, competitive landscape, and commercialization expectations, to provide a valuation benchmark for the market.

The core logic of an rNPV valuation is to discount the pipeline's future lifetime cash flows back to the present after multiple risk adjustments. The formula is: peak sales × clinical success probability × discount factor. Meanwhile, peak sales = target patient population × expected peak penetration rate × market share × annual treatment cost × clinical data quality coefficient × commercialization rights coefficient.

Where to begin the assessment

In terms of clinical success probability, 9MW1911's Phase IIa study in moderate-to-severe chronic obstructive pulmonary disease (COPD) reported positive results in November 2025, with the Phase IIb study currently underway and a Phase III trial expected to initiate by the end of 2026. Based on industry-recognized clinical success rate benchmarks, the probability for a drug at the Phase II stage is set at 0.40.

Regarding the total patient population, data from the National Health Commission and epidemiological research published in The Lancet indicate that China has approximately 100 million COPD patients. Among them, those with moderate-to-severe disease (GOLD II-IV) account for roughly 43.7%, equivalent to about 43.7 million patients. After further screening for patients with a history of frequent exacerbations (≥2 per year) who meet the clinical need for biologic therapy, the target patient population is approximately 10.9 million.

Key parameters and market outlook

For penetration, the peak penetration rate in this calculation refers to the long-term steady-state penetration of the entire ST2/IL-33 pathway inhibitor class among moderate-to-severe COPD patients with biologic therapy indications in China, serving as a measure of the overall maturity of the segment. Drawing on mature pharmaceutical markets in Europe and the US as a reference, COPD biologics, with their precision anti-inflammatory effects and significant reduction in exacerbations, are expected to achieve a long-term steady-state penetration rate of around 10%. As an upstream novel mechanism covering a broader population, including non-eosinophilic phenotypes, the ST2/IL-33 pathway could see penetration rise further to approximately 12%. Considering the ceiling for innovative drug penetration in China, mature-stage penetration for targeted therapies in the domestic market typically reaches 60%-70% of that in Europe and the US, corresponding to a baseline peak penetration of about 7.2%. Factoring in adjustments for China's tiered diagnosis and treatment system and grassroots accessibility, the revised peak penetration rate for a single indication is set at roughly 7%.

In terms of market share, in the global ST2/IL-33 arena, AstraZeneca's tozorakimab has already filed for marketing authorization in China, and Sanofi/Regeneron's itepekimab has completed Phase III trials. Domestically, aside from MABWELL-B's 9MW1911, competitors such as Chia Tai Tianqing and Akeso have similar products in early-stage clinical development. Considering the competitive landscape and commercial capabilities, we assign 9MW1911 an 18% market share assumption.

Regarding annual treatment costs, currently approved COPD biologics in China, such as dupilumab and mepolizumab, have annual costs of approximately RMB 35,000-40,000. As a novel target, ST2/IL-33 products are expected to command higher pricing for the original developer. Domestic innovative drugs typically adopt a follow-on pricing strategy, usually set at 60%-80% of the originator's price. Given that 9MW1911 is a domestic innovative drug with certain clinical value premiums, while also needing to align with the medical insurance payment system and market competition, we estimate its post-negotiation annual treatment cost to be around RMB 32,000.

Clinical evidence and quality assessment

Based on the Phase IIa data disclosed by MABWELL-B, the randomized, double-blind, placebo-controlled trial (RCT) of 9MW1911 in moderate-to-severe COPD enrolled 80 subjects, predominantly those with blood eosinophil counts below 300/μL. Dosing was administered every four weeks across 100 mg, 300 mg, 600 mg, and 900 mg dose groups plus a placebo arm. Over the 12-week observation period, a clear dose-response relationship was demonstrated. Notably, the high-dose groups showed strong efficacy signals: the 600 mg group achieved a 24% reduction in the annualized rate of moderate-to-severe exacerbations versus placebo, with severe exacerbations reduced by 47%; the 900 mg group saw an 81% reduction in moderate-to-severe exacerbations and a 100% reduction in severe exacerbations. The overall safety and tolerability profile was favorable, with adverse event rates comparable to placebo.

Benchmarking against the same-target originator product tozorakimab's confirmatory Phase III data, two large-scale Phase III trials (totaling 2,306 patients) demonstrated 52-week results showing a 29%-30% reduction in annualized moderate-to-severe exacerbation rates in the overall population and 29%-34% in prior smokers, with statistically significant benefits across all eosinophil subgroups. Overall, 9MW1911 employs a rigorous RCT design, with promising Phase II efficacy signals and high-dose groups showing potential superiority over competitors. However, given the early clinical stage, limited sample size, and short observation period, the reliability and generalizability of the data require further confirmation, warranting a clinical data quality coefficient of 0.75.

From a commercialization rights perspective, 9MW1911 is a Class 1 innovative drug independently developed by MABWELL-B, holding full development, manufacturing, and commercialization rights in Greater China. The company has established a mature in-house commercialization team with experience promoting four marketed products, covering a marketing network across 30 provinces in China, with no external sales royalties payable. Based on assessment criteria, the commercialization rights coefficient is set at 0.85.

Final valuation outcome

Based on the above parameters, the peak annual sales for 9MW1911's COPD indication in Greater China are calculated at approximately RMB 4.67 billion. For the discount factor, MABWELL-B, as an innovative drug company that has already achieved product commercialization with mature promotional capabilities, still faces higher R&D risk for 9MW1911 at Phase II versus later-stage pipelines, warranting a discount rate of 15%. On the timeline, 9MW1911 is expected to initiate Phase III by the end of 2026, with approval around 2029. Typically, innovative drugs require a 5-6 year ramp-up period to reach peak sales, targeting approximately 2035, roughly nine years from the present. Using compound discounting, the discount factor is approximately 0.28. Combined with the 0.40 clinical success probability, the final risk-adjusted net present value (rNPV) for 9MW1911's COPD indication in Greater China is approximately RMB 520 million.

Disclaimer: The peak sales, risk-adjusted net present value, and other figures in this article are model estimates based on public information and a series of subjective assumptions. They are intended solely to illustrate the valuation logic and do not represent official forecasts from MABWELL-B, nor do they constitute investment advice. Key parameters such as clinical success rates, penetration rates, market share, and annual treatment costs involve significant uncertainty, and actual results may differ materially from these estimates. Investors should make independent judgments and bear their own investment risks.

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