On September 17, Changchun High-Tech announced that its holding subsidiary Jinsai Pharmaceuticals had reached an allergen-specific immunotherapy (AIT) product cooperation with Denmark's ALK-Abelló A/S (ALK). The company will jointly develop and commercialize ALK's house dust mite (HDM) allergen-specific immunotherapy products in China, and obtain exclusive agency rights for three products independently developed by ALK in mainland China.

According to the agreement, Jinsai Pharmaceutical will pay an initial payment of €32.7 million and a €40 million registration milestone payment for the dust mite allergen sublingual tablet (ACARIZAX) in China. Jinsai Pharmaceutical will also cover the majority of future Phase III bridging clinical study and registration costs for adult and adolescent indications, while both parties will each cover 50% of the clinical study and registration costs for pediatric indications. Furthermore, depending on the sales performance of these products in the Chinese market, Jinsai Pharmaceutical may make subsequent sales milestone payments of €105 million. The total potential value of the collaboration is €177.7 million, equivalent to approximately RMB 1.49 billion at the current exchange rate.

The three products in this collaboration include two allergen-specific immunotherapy products and a skin prick test kit for mite allergen detection:

① House dust mite allergen preparation (Alutard): a subcutaneous immunotherapy house dust mite allergen preparation that is currently available in China;

② ACARIZAX®: This is the world's first sublingual immunotherapy tablet approved for allergic asthma and allergic rhinitis. It has received marketing approval from regulatory agencies in multiple countries and regions, including Europe, the United States, Russia, Australia, Japan, Singapore, South Korea, Hong Kong, and Taiwan. It is currently being used in the Greater Bay Area of China and the Boao Lecheng Medical Pilot Zone in Hainan Province, and is also conducting a Phase III bridging registration study in China.

③ Mite Allergen Skin Prick Kit (Anci): A skin prick kit for mite allergen detection that has been launched in China.

The cooperation rights expire on December 31, 2039.

Dust mites are the most common allergen in humans, and China has the largest number of dust mite allergy sufferers globally. However, this market is currently underdeveloped, with penetration rates remaining significantly low.

It is estimated that fewer than 1 million patients currently receive allergen-specific immunotherapy, leaving a large unmet clinical need, with the disease burden among children being particularly heavy.

ALK is the world's largest desensitization treatment company, with a global market share of over 45%.

Jinsai Pharmaceutical is a leading company in the domestic growth hormone field. However, with increasing pressure from centralized procurement, the company has been strengthening its R&D and continuously exploring new areas since 2021. Currently, Jinsai Pharmaceutical has established a deep presence in pediatrics, respiratory medicine, immunology, and other fields, and has accumulated extensive clinical development and commercialization capabilities.

The products of this collaboration will form deep product synergy with Jinsai Pharmaceutical's pediatric business, helping it to further build competitive advantages in new pediatric areas beyond its core area of growth hormone.

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