ProductionJumboplayingcardsResearch Institute of Sina Finance listed companies
Author: Tianli
Lung cancer is a major disease in all cancers, with a large number of patients and a significant increase in the number of patients. According to the latest cancer report released by the National Cancer Center, the number of new cases of lung cancer in China is as high as 1.06 million every year, and more than half of the patients with lung cancer are diagnosed with advanced stage, the prognosis is poor, there is a huge unmet demand for treatment.
According to histopathology, lung cancer can be divided into two categories: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), of which NSCLC accounts for about 80% of 85%. There are significant differences in NSCLC driving gene profiles between Chinese and western populations, squamous cell carcinoma and adenocarcinoma. In China, EGFR mutation accounts for 50%.Jumboplayingcards.3%.
At present, the first-line treatment of EGFR NSCLC generally use EGFR TKI,NCCN guidelines to recommend the first choice of oxitinib, CSCO guidelines recommend not only imported drugs such as oxitinib, but also domestic EGFR TKI such as ametinib, vermitinib and ectini. However, there is a common problem of drug resistance in existing EGFR TKI drugs, and patients still face the situation that there is no drug available after they no longer respond to EGFR TKI, and there are clinical needs to be met urgently.
Therefore, the potential therapy of drug resistance of NSCLC after TKI treatment has also become the focus of many innovative drug enterprises, including Columbine TROP2 ADC SKB264, Bailitianheng EGFR/HER3 double anti-ADC BL-B01D1, Kangfang biological PD1/VEGF double anti-AK112 and so on.
As the above three drugs have shown excellent efficacy and safety data in the early clinic, all of them are licensed to overseas drug companies with higher transaction amount. Among them, the fastest-growing AK112 has declared NDA in China, so Kangfang Bio has become one of the leading enterprises of innovative drugs favored by many investors.
However, accidents always come so suddenly. On the morning of May 24, the share price of Kang Fang, a leading company with double resistance, fell by as much as 42.77% on the day of the flash crash.
On the news side, Kang Fang Bio recently announced on ASCO2024 the research data of PD-1/VEGF double antibody (AK112) in the treatment of EGFR-TKi and NSCLC. In contrast, the three-phase clinical data disclosed this time may not be as expected. Phase III clinical data showed that the median PFS was 7.06 months, compared with 8.2 months in previous phase Ⅱ, and 50.6% in ORR, and 68.40% in phase Ⅱ.
Horizontal comparison (not head-to-head), Kangfang biological AK112 clinical effectiveness data may not be as good as Columbine's SKB264 and Baili Tianheng's BL-B01D1. Phase Ⅱ clinical data showed that the ORR of clenbuterol TROP2 ADC SKB264 in ≥ 2L (59.1% received third-generation TKI) was 60%, and the median PFS was 11.1 months. Ⅰ phase b clinical data showed that the ORR of Bailitanheng EGFR/HER3 double anti-ADC BL-B01D1 in ≥ 2L (89.5% had received three-generation EGFR TKI treatment) was 63.2%, and the median PFS was 6.9 months.
Therefore, although AK112 combined with chemotherapy significantly improves PFS and maintains controllable safety compared with chemotherapy alone in patients with failed EGFR-TKI treatment, investors still choose to "vote with their feet" under the risk of double antibody leading status. As an important valuation anchor of Kang Fang, the impact of weaker than expected clinical data of AK112 remains to be seen.