Source: Securities Times
Author: Wu Yongfang
$AKESO (09926.HK)$There was a sharp intraday dive on the 24th. At one point, it plummeted by about 45%, and the decline gradually narrowed in the afternoon. As of press release, the stock had fallen by about 20%, with a market value of about HK$32 billion.
According to market news today, Kangfang Biotech's AK112 treatment of non-small cell lung cancer treated with EGFR-TKI in China fell short of expectations.
Subsequently, the company responded that in 2024, the American Society of Clinical Oncology (ASCO) disclosed that AK112 had an HR of 0.46. This is the core data for evaluating clinical study results. The data results are excellent, and there are no claims that it falls short of expectations. Currently, with excellent results, the AK112-301 data has been accepted as an oral report at the 2024 ASCO Conference and will be published globally on June 1, according to the organizer's plan.
At the same time, the company announced that the National Drug Administration (NMPA) has approved the marketing application of the world's first bispecific antibody drug, Idafang (PD-1/VEGF), independently developed by the company. The indication is combination chemotherapy for the treatment of locally advanced or metastatic EGFR mutations progressing after treatment with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI).
Kang Fang Biotech said that Idafang (evosi injection) is the world's first PD-1/VEGF bispecific immunotherapy drug for tumors developed independently by the company. Idafang was approved for marketing by China's National Drug Administration in May 2024 to treat locally advanced or metastatic NSQ-nsCLC that progresses after treatment with EGFR-TKI.
Currently, Ivosi has comprehensively laid out all lung cancer patient groups. A number of head-to-head studies are being carried out, such as a phase III study of single-agent versus pabolizumab monotherapy for first-line treatment of NSCLC with PD-L1 expression, a phase III study of combined chemotherapy compared with tirelizumab combined with chemotherapy as first-line treatment of sqnsCLC, and a global multicenter phase III study of chemotherapy versus pabolizumab combined chemotherapy for first-line treatment of sqnsCLC. Currently, clinical trials covering 16 indications for gastrointestinal tumors, hepatocellular carcinoma, and colorectal cancer are ongoing.
After making reasonable inquiries about the company, the board confirmed that it was unaware of any other information or insider information required to be disclosed under Part XIVA of the Securities and Futures Ordinance (Chapter 571 of the Laws of Hong Kong) which could cause unusual fluctuations in the price or trading volume of the Company's shares or that must be disclosed to avoid false markets in the Company's securities.
Kang Fang Biotech also indicated that the company cannot guarantee that the company will eventually be able to successfully develop and sell Edafang (PD-1/VEGF). Shareholders and potential investors of the Company are requested to act prudently when trading the Company's shares.
Editor/jayden