In recent years, under the policy encouragement for the development of innovative drugs, enterprises that truly have innovative abilities, provide clinical value, and lead in pipeline advancement are emerging. Companies like Guangdong HEC CJ Pharm, which actively seek opportunities for strong alliances, have seen a sharp increase in value and continuously improved differentiation innovation capabilities.

Zhijing Finance and Economics APP learned that after the market closed on November 25th, Guangdong HEC CJ Pharm (01558) announced that the company, together with the offeror Guangdong HEC Technology Holding and the subsidiary of 3sbio (01530) Shenyang 3sbio, signed an authorization agreement regarding the benzenesulfonamides Ceflitinib.

It is worth mentioning that this BD cooperation is the second License-out cooperation transaction for Guangdong HEC Technology Holding since reaching a $0.9 billion BD trade with Apollo Therapeutics in November this year, highlighting the increasing recognition of the company's innovative value by more and more peers in the industry.

According to the terms of the agreement, Shenyang 3sbio will be granted the exclusive commercialization rights for benzenesulfonamides Ceflitinib for specific indications in China, while Guangdong HEC CJ Pharm will receive an initial payment of 60 million yuan and subsequent research, registration, and commercial milestone payments. The term of this authorization agreement is at least 15 years from the signing date to the first commercial sale.

For Guangdong HEC CJ Pharm, this collaboration undoubtedly accelerates the commercialization progress of the company's key innovative product benzenesulfonamides Ceflitinib, laying a foundation for broader commercialization in the future. On the other hand, it is conducive to the company's continued exploration and expansion of the application scope of FLT3 inhibitors in monotherapy or combination therapy, enhancing future commercial value. This plays a crucial role in stabilizing and improving the company's valuation, benefiting long-term investors in holding the company.

From the perspective of indications, AML is the most common subtype of leukemia in China, accounting for more than half of all leukemia patients. AML has a relatively low incidence rate in the population under 30 years old, gradually increasing with age, and the highest incidence rate among people over 70 years old, with a median age of onset at 68 years. AML progresses rapidly and has the highest mortality rate among leukemia subtypes. Due to its insidious onset and critical condition, clinical treatment of AML faces significant challenges.

Research has found that FLT3 is one of the most common mutations in acute myeloid leukemia. According to the Securities Times app, approximately 30% of newly diagnosed AML cases have FLT3 mutations, making the development of FLT3 inhibitors a hope for treating these AML patients. From a market perspective, the market size of FLT3 inhibitors in China reached about 4.5 billion RMB in 2022, an 18.4% year-on-year growth; it is expected that by 2027, the market size will exceed 10 billion RMB, with a compound annual growth rate of 17.6% during this period.

However, from the current perspective of treatment methods, domestically marketed drugs targeting FLT3 such as sorafenib and midostaurin belong to the first generation of FLT3 inhibitors. These inhibitors are generally non-specific multi-target TKI inhibitors, lacking specificity for FLT3, which can lead to off-target toxicity. Therefore, there is an urgent need for a new generation of FLT3-targeted drugs to meet the growing unmet treatment needs.

As a new generation, highly specific FLT3 inhibitor in the innovative pipeline of HEC73543, Bendamustine Hydrochloride HEC73543 tablets can block the continuous activation of the FLT3 signaling pathway caused by FLT3-ITD mutations, thereby inhibiting the unlimited proliferation and anti-apoptotic effects of AML cells, ultimately achieving the effect of treating AML. Compared to first-generation drugs, it has the advantage of low off-target effects and higher safety.

In terms of research and development progress, Bendamustine Hydrochloride monotherapy for relapsed/refractory AML is currently undergoing Phase III clinical trials in China. It is the first domestic high-selective FLT3 inhibitor to enter Phase III clinical trials in China. Its combination with chemotherapy for newly diagnosed AML patients is also being conducted in phase Ib/II clinical trials simultaneously. Early Phase I results showed high CR/CRh rates and good tolerance in AML patients.

Currently, HEC is rapidly advancing the Phase III clinical trials of Bendamustine Hydrochloride. As the commercialization of Bendamustine Hydrochloride approaches, HEC's focus on this product is shifting towards commercialization. HEC's announcement of a commercial partnership with 3sbio at this critical juncture is worthy of investors' attention.

Undoubtedly, HEC and 3sbio are leading domestic innovative drug companies, both with efficient marketing teams and strong commercial capabilities. The reason HEC chose to cooperate with 3sbio is that in recent years, 3sbio has established a relatively complete commercial promotion system in the field of blood diseases, which deeply complements the clinical value of Bendamustine Hydrochloride, helping it to quickly achieve multi-level coverage in hospitals and pharmacies at all levels after its launch, benefiting a wider range of Chinese patients and achieving a synergistic effect of '1+1>2.'

The advance payment and subsequent milestone payments brought by this cooperation will also provide substantial financial support for HEC in the large-scale global clinical trials of Bendamustine Hydrochloride, facilitating the smooth progress of related pipeline through the clinical research stage, reducing pipeline development risks, shortening the development cycle, and paving the way for the successive landing of HEC's future FLT3-targeted drug pipeline.

Currently, leveraging heavyweights such as HEC88473 and Bendamustine Hydrochloride for BD transactions has already unlocked the commercialization potential for HEC, gradually establishing a strong foundation in the international commercialization of innovative drugs. It is worth mentioning that the company currently has over 100 pipeline drugs in development, covering areas such as infections, chronic diseases, tumors, and many innovative varieties are in the mid-to-late stages of research and development, also possessing licensing-out potential, which is expected to open up broader BD transaction and cooperation space for the company.

In the current market environment that prefers 'companies with more certainty,' as a scarce and high-value biomedical investment symbol, Guangdong HEC Technology Holding holds numerous potential assets of innovative drugs, and its allocation value is constantly increasing.