Pharmaceutical companies related to COVID-19 rose sharply today. Jiangsu Hengrui Medicine announced that it plans to buy back shares of 600 million yuan to 1.2 billion yuan. In addition, there are also news to stimulate the market. For example, Everbright Securities released a research report that the American Society of Clinical Oncology (ASCO) conference will be held in Chicago, the United States, from June 2 to 6. Invited by the conference, multiple star pharmaceutical companies in China will soon disclose the latest clinical data of multiple products at the ASCO conference (2023), covering a wide range of disease fields, such as hematological malignancies, digestive tumors, and lung cancer. Referring to the impact of recent ASCO meetings on the innovative drug sector, the bank is optimistic that relevant innovative drug companies with positive clinical results will be disclosed at this ASCO annual meeting. At the conference, there will be 200 oral reports on research, over 2000 wall newspaper presentations, 46 clinical science seminars, and other cutting-edge academic achievements presented. Previously, Yasheng Pharmaceuticals announced that its four clinical studies were selected for this ASCO annual meeting; BeiGene will present multiple clinical research data of its tumor product portfolio at this ASCO annual meeting; Fuhong Hanlin stated that it will share the latest clinical research data of multiple products, including the anti PD-1 monoclonal antibody H drug Hans, at this ASCO. Today, innovative drugs are the mainstream of the market, with Hendy Pharmaceuticals reaching 20 centimeters. First Pharmaceuticals Holdings surged 13 centimeters to a new high, followed by a surge in the field of medical services and ophthalmology. Ho’s ophthalmology and Pratt’s ophthalmology have continued to soar. In fact, among the many rising pharmaceutical companies, Shouyao Holdings has been continuously rising since last month, and its stock price has risen by over 140% this year. However, Shouyao Holdings does not actually have many drugs listed, how can it support the continuous rise? The investment logic of innovative drugs is to see the future market sales of the company’s research products.
Why has Shouyao Holdings led the market up multiple times?
First Pharmaceutical Holdings is mainly engaged in research in the field of small molecule innovative drugs, mainly targeting common tumor targets with large indications, covering lung cancer, colorectal cancer, lymphoma, Multiple myeloma, hepatocellular carcinoma, breast cancer, pancreatic cancer and other multiple indications. The research and development pipeline has a clear hierarchy, including not only mature target products such as ALK inhibitors and BTK inhibitors, but also new star target products, such as “unlimited cancer” target RET inhibitor SY-5007 and pan tumor target WEE1 inhibitor SY-4835.
The pipeline contains many heavyweight products. For example, the second-generation ALK inhibitor SY-707 was enrolled in two key registered clinical trials, which were completed in August 2022 (the key phase II clinical trial for second-line use of clotozantinib resistant non-small cell lung cancer patients) and December 2021 (the phase III trial for first-line use of ALK positive patients). From the existing clinical research results, SY-707 demonstrates a competitive therapeutic level in the treatment of advanced ALK positive non-small cell lung cancer; In terms of safety, SY-707 has a lower overall incidence of adverse reactions related to eye diseases, Nervous system disease, skin and Subcutaneous tissue diseases, heart diseases and other aspects than similar drugs.
There are also products under research, SY-3505 and SY-5007. SY-3505 is the first fully domestically produced third-generation ALK inhibitor and the fastest progressing domestic third-generation ALK inhibitor in clinical research. Together with the second-generation drug SY-707, it has formed the only research and development layout in China to cover first-line, second-line, and third-line sequential treatment drugs for ALK positive non-small cell lung cancer patients. We have recently obtained CDE approval for conditional marketing eligibility for the treatment of patients with second-generation ALK inhibitor resistance. At present, Shouyao Holdings is launching multiple research centers nationwide to rapidly advance the critical Phase II clinical trial.
Existing clinical results have shown that SY-3505 exhibits competitive efficacy and safety data, demonstrating significant anti-tumor activity in ALK inhibitor resistant patients (especially second-generation drug resistance), with good tolerance and low incidence of adverse reactions.
From the perspective of the ALK inhibitor market, China should still have a large market. Before 2021, all ALK inhibitors entering the medical insurance market were imported products, but the market was not small. In 2021, the market size of China’s ALK inhibitor market was 3.46 billion yuan; With the gradual introduction and popularization of targeted drugs, it is expected that the ALK inhibitor market in China will reach 13.88 billion yuan by 2030, with broad market space. There are currently three generations of targeted drugs for ALK, such as the first generation of clotozantinib, which targets ALK, ROS1, and C-MET. The second generation includes Seretinib, Aletini, and Bugattini. The third generation has loratinib, which can inhibit almost all sites that lead to resistance to clotozantinib. Loratinib is the third-generation ALK inhibitor, which was first listed in the United States in 2018. At present, there is only one third-generation ALK inhibitor approved to be listed in the world, which can inhibit nine mutations resistant to coxotinib. It has a strong ability to penetrate the Blood–brain barrier, and has strong brain entry effect. It is suitable for advanced NSCLC patients resistant to other ALK inhibitors.
