China News Service, Beijing, October 11 (Luo Chunhao) An announcement caused the market value of a pharmaceutical company to evaporate by more than 10 billion yuan.
On October 8, Shanghai Ellis Pharmaceutical Technology Co., Ltd. (hereinafter referred to as Ellis) issued an announcement that a global Phase III clinical trial (FURVENT) of its core product fumetinib "failed to meet the primary study endpoint."
This was transmitted to the capital market. On October 8, Ellis stock fell to the limit (a drop of 20%), and its market value evaporated by more than 10 billion yuan in a single day. On October 9, Ellis continued to plummet 7.57%, and its market value decreased by 13.086 billion yuan in two trading days.
The response was so violent, and the global phase III clinical data "failed to meet the standards." What does this mean for Ellis? Let’s start with the targeted drug “vometinib”.
Fumetinib is a targeted drug mainly used to treat epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). It was independently developed by Ellis and will be launched in 2021. It has been approved for three domestic indications. According to Ellis's 2025 annual report, that year, the company achieved total operating revenue of 5.187 billion yuan, of which fumetinib sales revenue was 5.120 billion yuan, accounting for approximately 98.7% of total revenue.
In the field of innovative drugs, when many innovative pharmaceutical companies are still complaining that commercialization is difficult and R&D costs cannot be recovered, Ellis relied on a marketing team of about 1,800 people to achieve a net profit attributable to the parent company of 1.541 billion yuan in the first half of 2026.
Currently, Ellis's sales revenue mainly comes from the domestic market, and the development of overseas markets also depends on the progress of overseas clinical trials. Ellis' semi-annual report disclosed a few months ago showed that the company achieved revenue of 3.32 billion yuan in the first half of 2026, and fumetinib's full-year sales are expected to hit 6.5 billion yuan.
However, this clinical trial result directly put the brakes on Ellis' overseas narrative.
Billions of dollars are sold domestically every year, so why do overseas sales fail to meet the standards?
Judging from the currently announced indications of fumetinib, the overseas "failed to meet the standard" this time is the indication for the first-line treatment of NSCLC with EGFR exon 20 insertion mutations, which does not mean that there is a problem with the "vometinib" targeted drug itself.
Ellis has always had high hopes for this study, and the results will depend on the analysis of the complete data set and communication with regulators.
Pictured: Ellis’ core products and clinical R&D pipeline. Source: Ellis 2026 Semi-annual Report
The announcement released by Ellis shows that progression-free survival (PFS), assessed by the Blinded Independent Central Review (BICR), is the primary endpoint of the clinical trial. In the high-dose fumetinib 240 mg group, patients had a median PFS of 11 months compared with 9.5 months in the control chemotherapy group, with a hazard ratio (HR) of 0.75.
The announcement also stated that clinical benefits were observed on secondary endpoints such as investigator-assessed PFS and BICR-assessed confirmed objective response rate (ORR); although overall survival (OS) data are not yet mature, a clear improvement trend has been observed.
However, the PFS assessed by BICR did not reach the primary study endpoint, and this result is still a big impact on Ellis.
Global Phase III data "fails to meet standards", what impact will it have on star anti-cancer pharmaceutical companies?
From the perspective of competition, Dizhe Medicine's suvotinib has been commercialized in China and the United States, and has won the first-line treatment guideline with a successful global phase III; Johnson & Johnson's dual-antibody combination chemotherapy has already received formal first-line approval from the FDA, and can even hand over mature overall survival data. For Ellis, the hope of going overseas was once based on FURVENT data.
Secondly, there is the issue of milestone payment and how much you can ultimately get.
In June 2021, Ellis will exclusively license the global rights of "fumetinib" outside Greater China (Mainland China, Hong Kong, Macao and Taiwan) to the American pharmaceutical company ArriVent BioPharma. The consideration includes a down payment of US$40 million, a cumulative milestone payment of no more than US$765 million plus sales commissions and partial equity.
As of June 30, 2026, the cumulative milestone payments received by Ellis are approximately US$10 million. According to public reports, this US$10 million is only the portion of the highest US$765 million milestone payment in the agreement that has been realized, and most of the rest have not yet met the payment conditions.
In response to this clinical trial data, on October 9, the Shanghai Stock Exchange learned from Ellis that the company's commercial promotion and the global phase III of fumetinib's first-line treatment of EGFR PACC mutations are progressing smoothly. FURVENT research data needs to be analyzed in depth to determine subsequent development and regulatory communication plans.
Compared with other cases of innovative drugs going overseas, fumetinib is not a "new drug" with no revenue yet, but a mature product that has completed commercialization verification in China and continues to contribute cash flow. However, even if the "family wealth" is stronger, the overseas Phase III data for new indications "failed to meet the standards" still makes the uncertainty of innovative drugs going overseas highlighted again.
Data from Medical Cube shows that the total overseas transaction value of China’s innovative drug BD in 2025 will reach US$135.655 billion. According to SRS Acquiom data, among biopharmaceutical BD transactions as of 2025, there are 609 expired milestones, and only 136 have achieved milestone payments, with an achievement rate of only 22%. In terms of value, the fulfillment rate of pre-clinical milestones in global BD transactions is about 55%, which has dropped to 12% in the clinical phase III and only about 5% in the commercialization phase. (over)
