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一个月落定四笔交易!华东医药再获一款CAR-T产品独家商业化权益|速读公告

Four trades were secured in a month! Huadong Medicine has obtained exclusive commercial rights to another CAR-T product. | Speedy announcement.

cls.cn ·  Aug 4 21:24

Huadong Medicine announced that the company has signed an exclusive commercial cooperation agreement for a CD19-targeted CAR-T product. In the past month, Huadong Medicine has frequently taken actions, including acquiring traditional Chinese medicine companies and reaching drug commercialization cooperation.

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Caixin reported on August 4th that following the cooperation with Kexi Pharma, Huadong Medicine (000963.SZ) has signed another exclusive commercial cooperation agreement for a CAR-T product. The IM19 cell injection fluid involved in this agreement targets CD19. This is the fourth transaction that Huadong Medicine has completed in the past month, including the acquisition of traditional Chinese medicine companies.

Huadong Medicine announced tonight that its wholly-owned subsidiary, Huadong Medicine (Hangzhou) Co., Ltd. (referred to as "Huadong Medicine Hangzhou"), has signed an exclusive commercial cooperation agreement with Beijing Yimiao Shenzhou Medical Technology Co., Ltd. (referred to as "Yimiao Shenzhou").

According to the agreement, Huadong Medicine Hangzhou will obtain the exclusive commercialization rights of Yimiao Shenzhou's IM19 self-cell CAR-T candidate product, a CD19-targeted T cell receptor injection fluid, in mainland China. Huadong Medicine Hangzhou will pay Yimiao Shenzhou a down payment of 0.125 billion yuan and a registration and sales milestone payment of no more than 0.95 billion yuan. The payment will be made after the completion of relevant milestones.

It is reported that IM19 CAR-T cell injection fluid involved in this transaction is Yimiao Shenzhou's first CAR-T cell therapy product, which has received clinical trial approval notices for three indications from the National Medical Products Administration, namely, relapsed and refractory diffuse large B-cell lymphoma, acute B-cell lymphoblastic leukemia and mantle cell lymphoma, and has all entered the registration clinical research stage.

Among them, the study on the end-line treatment of diffuse large B-cell lymphoma is about to complete phase II clinical trials (confirmatory clinical trials), and it is expected to submit a drug application for marketing approval in the fourth quarter of this year. The research on acute B-cell lymphoblastic leukemia and mantle cell lymphoma has completed the return of all subjects in phase I, and will soon enter phase II clinical trials. In the future, Yimiao Shenzhou also plans to carry out clinical trials for the second-line treatment of diffuse large B-cell lymphoma.

Regarding this transaction, Huadong Medicine stated in the announcement that "CAR-T cell treatment, as a representative emerging treatment method, is expected to fill a huge market gap and bring new hope for blood tumor patients."

However, Huadong Medicine also pointed out the risks of this cooperation. The drug has not yet been approved for marketing, and there is uncertainty as to whether it can be registered and commercialized in the licensing area in the future. At the same time, there is a large uncertainty about whether the drug can achieve expected revenue and its impact on the company's interests.

It is worth noting that in March of this year, Huadong Medicine's exclusive CAR-T product ZEVALIN injection (trade name: Saikaze) was approved for marketing. The product was developed by Kexi Pharma, and is a self-cell CAR-T candidate product targeting BCMA, used to treat relapsed or refractory multiple myeloma adult patients who have progressed after at least 3 lines of treatment (at least one proteasome inhibitor and immunomodulatory agent have been used).

In addition to CAR-T products, Huadong Medicine has taken frequent actions recently. On July 19th alone, the company completed two transactions, including Huadong Medicine's wholly-owned subsidiary Bohua Pharmaceutical's plan to invest 0.528 billion yuan to acquire 100% equity of Hengba Pharmaceutical. It is reported that Hengba Pharmaceutical is an enterprise mainly engaged in the research and development of Miao ethnic medicine.

On the same day, Huadong Medicine's subsidiary, Sino-US Huadong, and Quanterix Biosystems, in which the company has a stake (02509.HK), signed a cooperation, development and marketing agreement for QX005N products.

Just recently, on July 12th, Sino-US Huadong and Ozon Pharmaceuticals signed an exclusive licensing agreement for Ida Plus Tablets, a self-developed improved new drug for the treatment of acute ischemic stroke, which has completed Phase III clinical studies in China. In this transaction, Sino-US Huadong will pay Ozon Pharmaceuticals an upfront payment of 0.1 billion yuan, a registration, sales milestone payment of no more than 1.185 billion yuan, and a graded net sales commission fee of up to two digits.

The translation is provided by third-party software.


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