Source: Finance Association
① Last night, Kangfang Biotech revealed to the outside world that positive progress has been made in head-to-head trials of evosimab compared to K drugs. The stock price skyrocketed today and plummeted a few days ago; ② Kangfang Biotech said that it has high expectations for evosimab and will promote marketing and entry into medical insurance as soon as possible; ③ Experts believe that whether evosimab has surpassed K drugs still requires further clinical trial results and confirmation of marketing review and approval.
$AKESO (09926.HK)$Investors have experienced a “roller coaster” in the past week. In advance of today's market, Kang Fang Biotech announced that a head-to-head trial of the core PD-1/VEGF dual antibody variety evosimab injection compared to K drugs obtained results, reaching the main research end point of progression-free survival (PFS). This also led to a sharp rise in Kangfang Biotech's opening today after a sharp decline a few days ago. At one point, the instantaneous increase was over 80%.
Kangfang Biotech held a business update meeting this morning to explain in detail the significance and value of the results of this clinical trial of evosimab injection, and stated that it will actively promote marketing and entry into medical insurance.
At the same time, industry experts believe that whether evosimab has surpassed K drugs still needs further confirmation of clinical trial results and marketing review and approval.
Does evosimab beat K head-to-head?
In advance of today's market, Kang Fang Biotech announced that the registered phase III clinical study (Harmoni-2 or AK112-303) of the world's first novel bispecific antibody drug (product name: edafang, PD-1/VEGF double antibody) showed strong positive analysis results compared with pabolizumab first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with positive PD-L1 expression (PD-L1 TPS ≥ 1%).: No progress has been achieved The primary research endpoint for survival (PFS).
The news also directly boosted Kang Fang Biotech's Hong Kong stock market. The opening stock price skyrocketed, reaching an intraday high of HK$60 per share, an increase of 87.5%. As of the midday break, the increase was still over 30%.
Notably, data from the HarmonI-2 (AK112-303) study showed that in the intended treatment group (ITT), the evosil group significantly extended the progression-free survival (PFS) of patients compared to the Pabolizil group, and the risk ratio (HR) was significantly better than expected. Evosil became the first and only drug in the world to prove that efficacy was significantly superior to pabolizumab (drug K) in a phase III single-drug head-to-head clinical study; efficacy analyses in all subgroups of the Evosil group showed strong positive results, including patients with or without squamous cell carcinoma, hepatic metastasis, and with/without brain metastases.
Kang Fang Biotech also revealed that detailed data from the HarmonI-2 (AK112-303) clinical study will be presented at an upcoming global academic conference.
According to reports, Evosil is the world's first new bi-specific antibody drug for cancer treatment with the “immunotherapy+antiangiogenesis” coordination mechanism. It can target PD-1 and VEGF targets at the same time. Prior to Evosi, no similar products or drugs with similar mechanisms of action had been approved in the world. Currently, Evosi has been approved for 1 indication globally, and 5 phase III clinical studies are being carried out. Of these, 2 international multi-center phase III clinical trials are being carried out overseas, and 4 are phase III clinical studies using PD-1 monoclonal antibodies as positive control drugs.
In particular, the HarmonI-2 study was the world's first phase III clinical study where single-agent therapy compared with pabolizumab monotherapy achieved significant positive results, and the subject of the head-to-head study, pabolizumab (drug K) was$Merck & Co (MRK.US)$The trump card variety reached the top of the global sales “Pharmaceutical King” with sales of 25 billion US dollars in 2023.
Xia Yu, founder, chairman, president and CEO of Kangfang Biotech, said in an article published early in the morning of GuanWei that in the HarmonI-2 study, the superior efficacy and safety of the single drug iVosi has further consolidated the huge potential of Ivorsi as a cornerstone product for tumor immunotherapy (IO), including broad clinical development value and market prospects in combination with ADC drugs or other novel anti-cancer drugs.
Targeted counterattack?
“Undoubtedly, this is Kangfang Biotech's response to the sharp drop a few days ago.” An industry person who has been following the biomedical sector for a long time told the Financial Federation reporter.
On the morning of May 24, the summary of the 2024 American Society of Clinical Oncology (ASCO) annual meeting was announced. Kangfang Biotech AK112, EGFR-TKI treated non-small cell lung cancer phase III clinical data in China was also disclosed in the abstract. Subsequently, news that the phase III clinical trial of evosimab combined chemotherapy and chemotherapy alone fell short of expectations also began to ferment. On the same day, Kangfang Biotech Hong Kong's stock price crashed. At one point, the biggest drop was over 42%.
The situation then began to change. At noon on the 24th, the State Drug Administration announced that it had passed a priority review and approval procedure to approve the marketing of evosimab injections. Kangfang Biotech also held an emergency business meeting at noon. At the meeting, Kangfang Biotech's management made an effort to explain to representatives and investors of participating institutions that the phase III clinical trial of evosimab did not fall short of expectations.
However, some in the industry believe that Kangfang Biotech's announcement today is not entirely a targeted counterattack. “Generally, phase III experiments take a long time, so if we talk about specific targeted counterattacks, we shouldn't be able to talk about this.” Cao Bo, medical doctor of innovative medicine, analyzed to the Financial Federation reporter that it is indeed necessary for Kang Fang Biotech to reveal some positive results and give investors and the market some confidence. The head-to-head comparison with K medicine itself is something Kangfang Biotech is proud of.
“In addition, Kang Fang Biotech's announcement today revealed a pre-set mid-term analysis. It was not an analysis carried out after the entire experiment was over. If the analysis after the entire experiment was completed, it means that one drug is much stronger than the other before it can have a strong positive result, which is very difficult.” Cao Bo added to the Financial Federation reporter.
In fact, this is not the first time that shares similar to Kangfang Biotech have changed drastically recently in the innovative drug sector. On February 5 this year,$Jiangsu Yahong Meditech (688176.SH)$At one point, the stock price fell by more than 19%, and the reason was that the key clinical data of APL-1202 in the R&D pipeline was not ideal, and it failed to reach the main research end point. In January of this year,$LAEKNA-B (02105.HK)$Topline data for treatment of platinum-resistant ovarian cancer (PROFECTA-II) with LAE002 combined with paclitaxel was released, showing that the end of the study was not reached. On the same day, Laikai Pharmaceutical's decline reached 36.31%.
Also, three days ago,$ALPHAMAB-B (09966.HK)$The latest progress in the phase III clinical trial of PD-L1/CTLA-4 dual antibody KN046 for the treatment of advanced pancreatic ductal adenocarcinoma (PDAC) was revealed, and the overall survival results did not reach the intended statistical end point. On May 29, after the opening of the market, Corning Jerry took a quick dive. At one point, it fell close to 58% during the intraday period, then the stock remained low. By the close, the stock had fallen 44.75%.
At around 9 a.m. this morning, Kang Fang Biotech held a business update meeting. The management of Kangfang Biology explained in detail the process and significance of the test results. Xia Yu also told participants, including a reporter from the Financial Federation, that she will actively communicate with the supervisory authorities as soon as possible to push for approval of the second indication of evosimab. Previously, the company had set specific sales targets for the first approved indication of evosimab, and will expand the commercialization team based on sales revenue in the future. Kangfang Biotech will actively participate in health insurance negotiations with a consistent attitude.
“Whether Kangfang Biotech's evosimab is actually superior to K drugs will have to wait until the relevant departments verify and examine their clinical data after applying for marketing, and compare them economically with other PD-1/PD-L1 and dual-antibody varieties that have already been marketed before making a conclusion. It's not that fast to get health insurance, and it won't have an impact on the relevant market in a short period of time.” Cao Bo said.
editor/tolk