Economic Observer reporter Liu Xiaonuo

On September 15th, Kangfang Biotechnology (09926. HK) released detailed data at the World Lung Cancer Conference (WCLC): its core product, Ivoxidan Antibody (hereinafter referred to as "Ivoxidan"), once again achieved results surpassing Pembrolizumab (hereinafter referred to as "K-drug").

On September 3rd, Kangfang Biotechnology announced the preliminary results. On the 4th, the stock price of Kangfang Biotechnology surged by 11.45%, and continued to fluctuate in the following days. On the 15th, Kangfang Biotechnology closed down 0.47%, at HKD 95.26 per share, with a total market value of HKD 87.74 billion.

Yvoxi is the world's first PD-1/VEGF drug used to treat various cancers, approved in China in May 2024. Due to its status as the first drug to surpass the "K-drug" in head to head clinical trials, its data has always been a focus of attention for the industry and investors.

K-drug "is Merck's core product and the cornerstone drug of current tumor immunotherapy. It will continue to be the global" drug king "from 2023 to 2024, with sales reaching 31.68 billion US dollars in 2025. Kangfang Biotechnology believes that Ecovacil can become the cornerstone drug of the next generation of tumor immunotherapy after "K-drug".

The data released this time is the results of the HARMONI-2 clinical trial conducted by Ecovaci. This is a phase III clinical trial in China, comparing the efficacy of Iveiximab with Pembrolizumab monotherapy for first-line treatment of locally advanced or metastatic non-small cell lung cancer with positive PD-L1 expression.

In May 2024, Kangfang Biotechnology announced for the first time that Ivosi had defeated "K-drug" based on HARMONI-2. At that time, Kangfang Biotechnology disclosed progression free survival (PFS) data, which refers to the time from the patient receiving treatment to the onset of disease progression. The median PFS for Ecovacil was 11.14 months, while for K-drug it was 5.82 months.

We were very happy at that time, and the international community and industry were also very encouraged by it, "recalled Xia Yu, founder and chairman of Kangfang Biotechnology, at a data interpretation meeting on September 13th. At that time, the primary endpoint set by Kangfang Biotechnology for these clinical trials was PFS, and overall survival (OS, survival time of patients from the start of treatment) was set as a key secondary endpoint.

However, OS is considered the gold standard for cancer treatment. The focus of attention from regulatory, academic, industrial, and investment sectors has gradually shifted towards OS indicators.

At this WCLC conference, Kangfang Biotechnology released the OS data of HARMONI-2. As of August 20, 2026, with a median follow-up time of 36 months, a total of 234 OS events occurred. Among the intention to treat population, the median OS of Ivosi was 30.8 months, and that of "K drug" was 22.6 months. Compared to the "K drug", Ivosi reduced the risk of death by 27%. Kangfang Biotechnology stated that the data reached the predetermined statistical significance and had clear clinical benefits, with outstanding benefits in the PD-L1 high expression subgroup.

Mariana Brand ã o, an on-site evaluation expert from the Jules Bordet Institute in Belgium, believes that "it is very interesting that these benefits seem to be mainly driven by the population with high PD-L1 expression; Surprisingly, it is also driven by the population with squamous cell carcinoma. Squamous cell carcinoma is usually a population with poor prognosis, but here it shows clear benefits. ”

Mariana Brand ã o stated that she does not believe she will immediately change the clinical practice of diagnosing and treating non-small cell lung cancer with high PD-L1 expression, as this is only a subgroup analysis under key secondary endpoints. Although Ivosi has good tolerance, its toxicity is higher compared to 'K drug'. In addition, so far, we do not have any other predictive biomarkers that can tell doctors which patients are particularly suitable for using Ivoxidan antibody. ”

But she also made it clear that she is excited about these data. I think this is really interesting. Now, of course, we have to wait for the global Phase III HARMONI-7 trial; This experiment is specifically targeting the population with high expression of PD-L1. ”

In December 2022, Kangfang Biotechnology will license Ecovaci to Summit, a US company, with a potential total transaction value of $5 billion. Summit will undertake Ecovaci's clinical development in some overseas markets such as the United States and Europe. In January 2026, the US Food and Drug Administration (FDA) accepted the marketing application of Ivosi based on another clinical trial, the global multicenter phase III clinical trial HARMONI. Summit previously disclosed that the FDA expects to make a review decision on November 14, 2026.

Since 2025, Summit has repeatedly released overseas clinical trial data for Ecovaci, which has caused significant fluctuations in stock prices due to issues such as lower than expected OS data.

In May 2025, Summit disclosed that in the HARMONI study, the primary OS analysis prior to the combination therapy of ezetimibe and chemotherapy did not reach statistical significance; Although follow-up updates have shown an improvement in the OS risk ratio, the results that have reached the predetermined statistical significance have not yet been disclosed.

At this WCLC, Summit updated and released HARMONI's data. The company stated that in the Western patient population, with the extension of follow-up time, patients in the Ivosi group have continued to improve, indicating consistency of Ivosi in different regions.

In the first half of 2026, Kangfang Biotechnology achieved a revenue of approximately 1.8 billion yuan, a year-on-year increase of 27.92%, mainly relying on the sales of two core products, Ecovaci and Cardoni. For Kangfang Biotechnology, the launch of core products such as Ecovacis in the United States is the only way to obtain excess returns in overseas markets, but this still depends on the overseas development status, regulatory attitude, and competitive landscape in the same treatment field.

(Author Liu Xiaonuo)