NO.1 Xinda Biotech and Eli Lilly reach commercial cooperation on third-generation BTK inhibitors

On December 16th, Xinda Biotechnology and Eli Lilly and Company Limited jointly announced the following cooperation agreement regarding the rights and interests of Eli Lilly and Company Limited's non covalent (reversible) BTK inhibitor "Jepanib" (100mg and 50mg tablets of Pitobutinib): Xinda Biotechnology will be responsible for the import, sales, promotion, and distribution of "Jepanib", while Eli Lilly and Company Limited will be responsible for the research and development of "Jepanib" and post marketing medical affairs. This drug is the latest generation, the world's first and only approved non covalent (reversible) BTK inhibitor.

Comment: Eli Lilly and Company is a long-term partner of Xinda Biotechnology. In the past 10 years, the two parties have reached 5 cooperation agreements. The promotion of this cooperation can not only enable Xinda Biotechnology to obtain cash flow and enrich its own pipeline, but also endorse the development and commercialization capabilities of domestic innovative drug companies. Therefore, it is expected to enhance Xinda Biotechnology's market position in the field of tumor treatment and strengthen the investment confidence of the company's investors.

NO.2 Yuanda Pharmaceutical's innovative ophthalmic drug domestic NDA application accepted

On December 16th, Yuanda Pharmaceutical announced that the group's globally innovative ophthalmic drug GPN01768 (TP-03, Lotelana eye drops, 0.25%) for the treatment of demodex blepharitis has officially submitted a new drug application (NDA) to the National Medical Products Administration and has been accepted. This drug is the world's first and only product approved by the US Food and Drug Administration (FDA) for the treatment of demodex blepharitis. Yuanda Pharmaceutical partnered with Tarsus Pharmaceuticals in March of this year, Inc. has reached a strategic cooperation agreement for product introduction.

Comment: This drug is expected to fill the gap in the domestic market, enhance the competitiveness of Yuanda Pharmaceutical in the field of ophthalmology, and have a positive impact on the company's stock price and market position. In addition, Yuanda Pharmaceutical has also reserved multiple global innovative products for the treatment of "myopia", "dry eye syndrome", "pterygium", "anti-inflammatory and analgesic effects after ophthalmic surgery", "demodex blepharitis" and "meibomian gland dysfunction caused by demodex mites". In the next three years, multiple innovative products are expected to be approved for market launch.

Two raw materials of Shisiyao, NO.3, have been approved and registered by the National Medical Products Administration

On December 16th, Shisi Pharmaceutical Group announced that its fumarate furosemide has been approved and registered by the National Medical Products Administration as a raw material for use in marketed formulations. Fumarate furosemide is mainly used to treat reflux esophagitis. The board of directors also announced that the group's dronedarone hydrochloride has been approved by the National Medical Products Administration to be registered as an active pharmaceutical ingredient for use in marketed formulations, making it the third domestic enterprise to receive approval. dronedarone hydrochloride is an antiarrhythmic drug.

Comment: The approval of two drug raw materials by Shisi Pharmaceutical Group will enhance the company's market competitiveness and product line in related fields. Specifically, as the third domestically approved antiarrhythmic drug, dronedarone hydrochloride has a first mover advantage; Fumarate furosemide is used to treat reflux esophagitis, and the corresponding number of patients in China has reached 165 million. Therefore, for the capital market, these two pieces of news may boost investor confidence and increase the attractiveness of company stock prices.

NO.4 North China Pharmaceutical subsidiary withdraws drug registration application

On December 16th, Huabei Pharmaceutical announced that its wholly-owned subsidiary, Shenzhen Huayao Nanfang Pharmaceutical Co., Ltd. (referred to as Nanfang Company), submitted a marketing authorization application for injectable polymyxin B to the National Medical Products Administration in January 2024 and was accepted. Due to the need to further improve the pharmaceutical research application materials for injectable polymyxin B, Southern Company has submitted an application to withdraw the registration of injectable polymyxin B to the National Medical Products Administration. Recently, the National Medical Products Administration agreed to allow Southern Company to withdraw its drug registration application.

Comment: According to the official website of the National Medical Products Administration, as of now, no domestic enterprise has obtained the approval for the consistency evaluation of this variety. The sales amount of injectable polymyxin B sulfate for "urban public, county-level public, urban community, and township health" in China in the first quarter of 2024 was 350 million yuan, as queried through the MiNet. The withdrawal of the registration application for injection grade polymyxin B by Southern Company this time will not have a significant impact on the company's current performance, but may affect the expectations of some investors.

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