On November 27, Kelenbotai Biology announced that the company's first antibody drug conjugate (ADC) targeting human trophoblast surface antigen 2 (TROP2) for unresectable local advanced or metastatic triple negative breast cancer (TNBC) adult patients who have received at least two kinds of systematic treatment in the past (at least one of which is for advanced or metastatic stage), sac-TMT (formerly SKB264/MK-2870) (Gatalay), was approved by the State Food and Drug Administration to be listed in China. This drug is the first domestically produced and the second globally approved TROP2 ADC drug.

Comment: This incident has certain significance for both the company and the domestic innovative pharmaceutical industry. China has become a core participant in global ADC research and development. There are companies in China with strong ADC technology platforms, companies that have accumulated differentiated ADC clinical drugs and strong commercialization capabilities, or companies that have comprehensive and rich technical capabilities and can provide ADC outsourcing services. They all have the potential to become industry leaders.

NO.2 East China Medicine's ovarian cancer new drug and self exempt new drug were approved for market on the same day

On November 27th, Huadong Pharmaceutical announced that its wholly-owned subsidiary Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. has received the "Drug Registration Certificate" approved and issued by the National Medical Products Administration. Soracizumab injection (Elaher/ELAHERE) has been approved for the indication of folate receptor alpha positive platinum resistant ovarian cancer (PROC) that has previously received 1-3 line systemic therapy; Linacecept for injection (Yanduo/ARCALYST) is approved for the treatment of adult and adolescent cold pyridine related cyclic syndromes (CAPS), including familial cold autoinflammatory syndrome (FCAS) and Muckle Wells syndrome (MWS), aged 12 years and older.

Comment: Huadong Pharmaceutical has accumulated commercial resources through the sales of generic drugs in the past. The approved Somitumumab injection is the first and currently the only ADC drug targeting FR alpha (folate receptor alpha) approved for the treatment of PROC in China, the United States, and the European Union. Its approval will have a positive impact on the company's future performance and also means that the company's innovative products have entered a period of realization. The progress of commercialization work is worth paying attention to.

NO.3 Kanglong Huacheng plans to invest an additional 10.5 million US dollars in the joint venture company

On November 27th, Kanglong Huacheng disclosed that its joint venture company PharmaGend Global Medical Services Pte. Ltd. plans to conduct additional financing based on its operational situation and funding needs, and has issued a total of $30 million in additional financing requests to all investors. After fully considering the use of funds and budget plan of the joint venture company, all investors plan to jointly invest an additional $30 million in the joint venture company according to their respective shareholding ratios. Among them, Kanglong Hong Kong International, a wholly-owned subsidiary of Kanglong Huacheng, holds 35% of the equity of the joint venture company. This time, it is proposed to invest an additional $10.5 million in the joint venture company with its own funds.

Comment: This event is beneficial for Kanglong Chemical to collaborate with partners to expand its CDMO service capabilities in Southeast Asia, promote the development of joint ventures, and provide customers with better services and solutions, further promoting the company's global, high-quality, sustainable and healthy development. This news may have a positive impact on Kanglong Huacheng's stock price, increasing market expectations for its and its joint venture's future performance.

NO.4 Chinese biopharmaceutical Class 1 innovative drug approved for new indications

On November 27th, China Biopharmaceuticals announced that the group's independently developed Class 1 innovative drug, pembrolizumab injection combined with anlotinib hydrochloride capsules, has been approved by the National Medical Products Administration for the treatment of recurrent or metastatic endometrial cancer with non microsatellite highly unstable (non MSI-H) or non mismatch repair gene defects (non dMMR) that have previously failed systemic anti-tumor therapy and are not suitable for radical surgery or radiotherapy. This is the second indication approved for Beimosubizumab injection in China, and the seventh indication approved for Anlotinib hydrochloride capsules in China.

Comment: In recent years, China's biopharmaceutical industry has continued to promote the development of innovative products, fully tapping into product potential, and news of innovative drugs being approved for market has been frequent. The approval of new indications for Class 1 innovative drugs this time will further improve the layout of Chinese biopharmaceuticals in the field of oncology. With the increasing sales of newly approved drugs, the company is expected to usher in a second growth point, enhancing investors' confidence in its innovation capabilities.

NO.5 The world's first nasal spray for the treatment of dry eye symptoms and signs was approved in China

On November 27, Jixing Pharmaceutical announced that the State Food and Drug Administration had approved its new drug marketing application for the ophthalmic product Varnikolan Tartrate Nasal Spray (Star Run) to increase the tear secretion of dry eye patients. In October 2021, Vanidam nasal spray was approved by the US FDA, becoming the world's first and only nasal spray approved for the treatment of dry eye symptoms and signs. The approved data is based on the results of three key clinical studies involving over 1000 dry eye patients worldwide, as well as large-scale multicenter randomized double-blind controlled clinical studies completed in China in phases I and III.

Comment: Chinese dry eye patients have welcomed the world's first and only nasal spray medicine, which is expected to change the traditional dry eye treatment mode and further expand the market scale of dry eye treatment. At present, the listed companies that have laid out drugs for dry eye include Xingqi Eye Medicine, Gaoshi Medical, Aisiya, Bigway Medical, Dingshi Medical, Kerun Biology, Tianchen Biology, Weiqing Medical, Xianwei Medical, Zhongjing Weishi, etc.

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