港股公告掘金 | 对外战略合作再下一城 全球首款且唯一R/R ENKTL免疫治疗药物获批开拓海外市场

Hong Kong Stock Announces Nuggets | Strategic Cooperation with Foreign Countries: World's First and Only R/R ENKTL Immunotherapy Drug Approved to Open Overseas Markets

Zhitong Finance ·  11/09/2023 08:25

Puget is a potent, highly selective inhibitor that accurately targets RET targets.

[Headline announcement Nuggets]

Cornerstone Pharmaceutical (02616): Joining hands with Alice to jointly develop the Chinese market in Phuket

The Zhitong Finance App learned that on November 8, Cornerstone Pharmaceutical announced that it will grant the exclusive commercialization rights for Puget Hua (platinib capsules), the first RET inhibitor in China in mainland China, to Alice Pharmaceutical (688578.SH), a company listed on the Science and Technology Innovation Board (). Cornerstone Pharmaceutical continues to own rights other than Puget Hughua's R&D and registration promotion rights in mainland China.

Comment:Puget is a potent, highly selective inhibitor that accurately targets RET targets. It is the first RET inhibitor in China. Puget Huff has received full approval for first-line and second-line non-small cell lung cancer indications in both the US and China, and also covers thyroid cancer. It is expected to be used in more cancer fields in the future, such as colorectal cancer, gastric cancer, breast cancer, liver cancer, cervical cancer, nest cancer, and esophageal cancer. The two major indications approved by Puget Huat have huge market potential. In the field of lung cancer, China had about 820,000 new lung cancer cases and 710,000 deaths in 2020. Non-small cell lung cancer accounted for the majority of lung cancers. In the field of thyroid cancer, there were about 220,000 new cases of thyroid cancer in China in 2020. According to some agencies, Puchi Huay's domestic sales are expected to reach 600 million, 860 million and 1.27 billion dollars from 2024 to 2026. The strong partnership between Cornerstone Pharmaceutical and Alice Pharmaceutical is expected to leverage synergies in the field of lung cancer indications, promote continued rapid sales growth in Phuket, and greatly reduce commercialization costs. Cornerstone Pharmaceutical will receive a down payment and subsequent R&D milestone payments, and will continue to receive sales revenue from Puget Huai's sales in mainland China. Additionally, Keystone Pharmaceutical and Sansheng Pharmaceutical reached a strategic cooperation and exclusive licensing agreement for Nofazinlimab (anti-PD-1 monoclonal antibody) in mainland China. Recently, Cornerstone Pharmaceutical announced that China's National Drug Administration (NMPA) has approved its potential best-in-class PD-L1 antibody to select Jiemei (suglimab injection) for treatment of patients with recurrent or refractory extranodal NK/T-cell lymphoma (R/RENKTL). As a result, Zejiemei became the world's first and only cancer immunotherapy drug approved for R/RENKTL indications. After stage III and stage IV non-small cell lung cancer (NSCLC), this is the third indication Zechemei has been approved for in China. Successful development in a wide range of indications is expected to further bring greater potential to Zechemei in overseas markets. It is also the approval of the 12th new drug marketing application that Cornerstone Pharmaceutical has received since its establishment.

[Key Announcements Nuggets]

Fosun Pharmaceuticals (02196): Aohong Pharmaceutical was approved as a marketing license holder for desmopressin oral solution to accelerate international market layout

According to the Zhitong Finance App, Fosun Pharmaceutical announced that Aohong Pharmaceutical, a holding subsidiary of the company, recently received the “Notice of Approval of Supplemental Drug Applications” issued by the State Drug Administration for the oral solution of desmopressin. The marketing license holder (MAH) for the drug was changed from Nanjing Haina Pharmaceutical Technology Co., Ltd. to Aohong Pharmaceutical. The company achieved operating income of 30.70 billion yuan in the first three quarters, net profit attributable to shareholders of listed companies of 2,283 billion yuan; net profit attributable to shareholders of listed companies after deducting non-recurring profits and losses of 1,474 billion yuan.

Comment:This time, Aohong Pharmaceutical, a subsidiary of the company, has been approved as the marketing license holder for this drug, which will further enrich the group's product line. Since the first indication was marketed in March 2022, the PD-1 product Hans (slulizumab injection) has continued to be dosed. Fosun Pharmaceuticals is also speeding up its international market layout. According to the latest information disclosed by Fuhong Hanlin, the company announced that it has reached a cooperation with Intas Pharmaceuticals Limited to grant it the right to exclusively develop and commercialize the anti-PD-1 monoclonal antibody H drug developed independently by Fuhong Hanlin in Europe and India for a number of indications and specific dosage forms, including extensive small cell lung cancer (ES-SCLC), including extensive small cell lung cancer (ES-SCLC). Previously, Fuhong Hanlin had already cooperated with Accord, a subsidiary of Intas, in June 2018, to grant it exclusive commercialization rights in Europe, parts of the Middle East and North Africa, and some CIS countries, and further granted Intas Han Quyou exclusive development and commercialization rights in the US and Canada in 2021. As for weight loss drugs that have recently become popular, as of August this year, China has 43 clinical trial programs for new GLP-1 weight loss drugs, accounting for 40% of the world. Fosun Pharmaceutical has entered phase III clinical trials and is ahead in research and development progress. The company's poor performance in the first three quarters was affected by unfavorable conditions, and marginal improvements are expected after calculation. Recently, Fosun Pharmaceutical received an increase in the majority shareholders' holdings. On the same day, Fosun Hi-Tech, the controlling shareholder of the company, increased its A-share holdings to a total of 720,000 shares with its own capital of about RMB 2.082 million, based on confidence in the company's future development prospects and recognition of its intrinsic value.

[List of important Hong Kong stock announcements]

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