[headline announcement Nuggets]
Kangfang Bio-B (09926): enter into a general procurement agreement with Zhengda Tianqing for III phase registered trial materials and services for the treatment of hepatocellular carcinoma with Paiampril.
Kangfang Biological-B announced that on September 20, 2022, Tianqingkang Fang, a subsidiary of the company, entered into a general procurement agreement with CP Tianqing for the III phase registration trial of sending Ampril in the treatment of hepatocellular carcinoma. Tianqingkang agreed to purchase and CP Tianqing agreed to provide clinical materials and clinical services.
Comments:The company is the leader in the field of double resistance, and a number of products in the research pipeline have entered a critical clinical period. In the first half of the year, R & D expenditure was 595 million yuan, an increase of 5.66% over the same period last year. The strategic focus is to promote clinical phase projects, focusing on phase 3 and registration phase clinical projects, including AK104 combined chemotherapy for first-line gastric and cervical cancer, AK112 (PD-1/VEGF), AK101 (IL-12/IL-23) and AK102 (PCSK9) multiple III phase clinical projects, AK117 (CD47) and other Ib/II phase projects.
PD-1/CTLA-4 double anti-cardinide was approved to market on June 29th, becoming the first double immunosuppressant target in the world and the first domestic double antibody in China. Cadonilizumab, the company's first innovative drug in charge of commercialization, issued its first prescription on July 5 and achieved a pre-sale of 100 million yuan in loans. The company has a commercialized team of more than 650 people and is optimistic about the rapid sales of cadunilib.
The use of piemizumab in the treatment of recurrent / refractory Hodgkin's lymphoma, first-line chemotherapy in combination with squamous NSCLC, second-line therapy or salvage treatment for recurrent / metastatic nasopharyngeal carcinoma has been included in the updated CSCO guidelines in version 2022, which is expected to meet the needs of clinical patients more quickly. A number of applications for listing indications are expected to be approved in the second half of the year, and the release of Paipril is expected.
[key announcement Nuggets]
Junshi Bio (01877): approval of new indications for first-line non-squamous non-small cell lung cancer treated with triplizumab combined with chemotherapy
Junshi Biology issued a notice that the company received the Drug Registration Certificate approved and issued by the State Drug Administration, Triplizumab (trade name: Tuoyi ® Product code: JS001) combined with pemetrexed and platinum for epidermal growth factor receptor (EGFR) gene mutation negative and anaplastic lymphoma kinase (ALK) negative, unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) new indications for first-line treatment have been approved.
Comments:Junshi Biology is an innovation-driven biopharmaceutical company. It has a complete industrial chain capacity from the discovery and development of innovative drugs, clinical research on a global scale, mass production to commercialization.
At present, the company's product lines have been expanded to 51, and the products under research involve 7 forms of drugs, covering five major treatment areas: tumor, metabolism, immunity, infection and nerve. Among them, there are 3 products in the commercial stage, 23 products in the clinical trial stage, and more than 25 products in the preclinical development stage.
Prior to May 10, the company developed COVID-19 specific drug VV116 has been listed in Uzbekistan. VV116 can significantly improve the clinical symptoms of patients, increase the SARS-CoV-2 clearance rate of patients, reduce the risk of critical illness and death by 92%, and have good safety and tolerance. After listing, fill the gap in the domestic market of self-developed COVID-19 small molecular drugs.
On June 7th, the company announced that the clinical trial of JS116, a small irreversible covalent inhibitor of KRASG12C with a new structure, has been approved for the treatment of patients with non-small cell lung cancer (NSCLC) with KRASG12C mutations. At present, there is only one targeted drug for KRASG12C in the world. JS116 makes it a global leader in targeted drug technology for KRAS mutated cancer.
Smoore International Holdings Limited (06969): Shenzhen Maishi Technology received the license of tobacco monopoly production enterprise.
Smoore International Holdings Limited announced that on September 20, 2022, another wholly-owned subsidiary of the company, Shenzhen Maishi Technology Co., Ltd. received a tobacco monopoly production enterprise license issued by the Tobacco Monopoly Bureau. the validity period is from September 5, 2022 to September 30, 2023.
Comments:Seymour Group is a global leader in providing atomization technology solutions. The main business is divided into (1) electronic atomization equipment and components and (2) own-brand advanced private e-cigarette equipment (APV) research, design, manufacturing and sales business. We note that according to the latest data, Yiwei LiNeng is the company's second largest shareholder, accounting for 31.64%.
According to the plan at the beginning of the year, the company plans to increase R & D spending by 1.68 billion in 2022 (more than the sum of the past six years), and the rate of medium-and long-term R & D spending may reach 10%, of which basic research covers no less than 30% of basic disciplines. Build a comprehensive atomization technology platform, pay more attention to building long-term competitiveness than short-term performance.
Previously, the company's wholly-owned subsidiaries Shenzhen Weiplai, Shenzhen McWeir, Shenzhen McBrothers, Jiangmen Moore and Dongguan Mike Electronic Technology were granted tobacco monopoly production enterprise licenses. So far, a total of 6 subsidiaries of the group have obtained the license of tobacco monopoly production enterprise.
The announcement said that the issuance of the above license has further enhanced the group's confidence in future development. The overall production and operation of the group will be carried out as planned.
[list of important announcements for Hong Kong stocks]