Hansoh Pharma's Small Step, a Giant Leap for Chinese Pharma Globalization

Another ChinaBICMolecules Go Global.Recently,EGFR-TKIAmeitinib Approved for Marketing in the UK, Becoming Hansoh Pharma's First Self-developed New Drug Approved Overseas and the First China-developed Third-generationEGFR-TKIApproved for marketing in Europe, this is a key move and a milestone moment in the internationalization of Hansoh Pharma's innovative achievements.

In recent years, the "highlight moments" of many domestically produced original new drugs going overseas have jointly built up the great journey of China's innovative drug internationalization.

RelayBiotechAfter the company, Ameitinib became the first one produced in China.PharmaThe innovative drug originally developed by the company and launched in the European market not only represents a new height reached in the innovative transformation of traditional Chinese pharmaceutical enterprises but also ushers in a new chapter of globalization for Chinese pharmaceutical companies.

It can be said that the small step taken by Hansoh is a big step forward for Chinese pharmaceutical companies on the road to internationalization.

As the first China-developed third-generation [product] to be launchedEGFR-TKI，The development history of Aumetinib itself is a vivid epitome of the growth of China's innovative drug industry. From breakthroughs in the Chinese market to stepping onto the international stage, the halo above Aumetinib continues to grow, with each advancement narrating the enhancement of innovation capabilities among Chinese pharmaceutical companies.

The birth of Aumetinib stems from Hansoh Pharma's vision to meet the clinical needs of lung cancer patients. Hansoh's drug research and development team utilized various strategies in its design.200more than compounds, and determinedHS-10296(i.e., Ameitinib) as a preclinical candidate compound (PCC）^[1]The team's meticulousness in molecular design has eventually paid off — the core invention patent of Aumolertinib has won the Gold Award of Chinese Patent.^[2], whose innovative value has been highly recognized, laying a solid intellectual property foundation for its internationalization journey.

2019In the same year, Aumetinib received support from the national "Major New Drug Creation" science and technology major project, and its market application was submitted. Soon after, Aumetinib was approved for marketing through the priority review channel in the following year, breaking the monopoly of the imported original drug Osimertinib. This is not only a commercial success but also brings good news to Chinese patients.

In the Chinese market, Aumetinib has shown strong growth momentum. It was approved in just five years.4Indications, from second-line treatment to first-line treatment and then to adjuvant treatment,Ameitinib Achieves Non-Small Cell Lung Cancer (NSCLC) Full-course treatment coverage, becoming the leader of the third generationEGFR-TKIThe backbone of competition.

Source: PharmaCubeNextPharmaDatabase

Clinical practice has proven that Aumetinib balances efficacy and safety, and is effective in inhibiting the central nervous system (CNS) has shown significant effects in the progression of metastatic lesions. These clinical values are key to its rapid recognition by doctors and patients, and also lay the foundation for its internationalization path.

The overseas journey of Ameitinib has not been smooth sailing. The regulatory standards and market access in the European pharmaceuticals market have always been stringent, fromNDAFrom acceptance to approval, Ameitinib has undergone a three-year long wait. This approval in the UK means that this molecule from China is gradually gaining recognition in the international market, and also paves the way for subsequent approval by the European Medicines Agency (EMA) provide important reference for the review, accelerating its marketing process in more overseas countries.

More importantly, this approval highlights Hansoh's determination to strongly join the global competition.Hansoh Pharma Chooses to Directly Challenge the Core Battlefield of Osimertinib — First-line and Second-line Treatment with AlmonertinibNSCLC, rather than starting with smaller indications, fully showcasing China's potentialBest in Class（BIC) Molecular Competitiveness.

Behind this strategy is Hansoh Pharma's clear positioning of Aumetinib:This is not a domestically innovative drug produced only for Chinese patients, but a globally innovative drug targeting patients worldwide.This requires Ameitinib to take clinical value, rather than price advantage, as the core competitiveness of the product, which is also the key to its ability to gain a foothold in the international market.

The global success of Ameitinib is validating a viewpoint: By adhering to high-quality innovation, Chinese pharmaceutical companies are fully capable of developing innovative drugs with global competitiveness.

Through the globalization story of Ameitinib, it can be clearly perceived thatHansoh's innovative transformation has achieved initial success, gradually moving away from low-level competition and aligning with international high standards. The leap in capability naturally brings more overseas value realization.

In fact, for a long time in the past, the industry was not very optimistic about the transformation of traditional pharmaceutical companies and had reservations about their ability to innovate and develop. However, the report card submitted by Hansoh Pharma has truly broken everyone's inherent perception of traditional pharmaceutical companies.

On the one hand, Hansoh has built a series of innovative pipelines with global competitiveness through independent research and development, carrying out differentiated designs in core development elements such as targets, drug types, and indications, and securing a favorable position in track competition. According to the PharmCube database, Hansohn already has38In-house Innovative Pipeline Project Enters Global R&D TrackTOP5The ranks.

High-quality pipelines will not lack appreciation from connoisseurs, and some projects have already surfaced for external licensing.B7-H4 ADCNew DrugHS-20089、B7-H3 ADCNew DrugHS-20093、Oral Small MoleculesGLP-1DrugHS-10535 andGLP-1/GIP Dual Receptor AgonistHS-20094Successively ObtainedGSK、Favored by Merck and Regeneron, 4The total amount of the deal exceeds 70Billion US dollars.

Under the wave of internationalization, many pharmaceutical companies in China are vigorously advancing overseas.BDTransactions, but beneath the surface glory, the gold content of each transaction actually varies significantly, which can be seen from the transaction amount and the buyers.

A straightforward trading logic is that everyone is pursuing a higher amount of money, hoping to obtainMNCendorsement and support, but there are not many transactions that meet both of these criteria.According to the PharmaCube database, the total transaction amount is15More than 100 million US dollars and the introducing party isTOP20 MNCThe deal in China's innovative druglicense-outAccounted for only in China6%（27/426), while Hansoh has3This transaction ranks first among Chinese pharmaceutical companies, demonstrating its high value.

Reached 15 with TOP20 MNCMore than $100 millionChinese Pharmaceutical Enterprises Involved in the Transaction

On the other hand, Hansoh is also learningMNCThe development model strengthens the layout in key disease areas by introducing innovative assets with high clinical value.

In the past year or so, Hansoh Pharma first expanded its cooperation with Promab.EGFR/cMetDouble AntibodyPM1080/HS-20117On the Basis of Further Development of Bispecific AntibodiesADC, the upgrade of drug types is expected to enhanceNSCLCAnd other cancer clinical benefits. Afterwards, based on the significant unmet needs in China's autoimmune field, Hansoh Pharma introducedIL-23p19Monoclonal AntibodyQX004NMonoclonal Antibodies and Lu Peng Pharmaceutical's New GenerationBTKInhibitorLP-168。

Thanks to "self-developed+The introduction of the "dual-driven strategy" has enabled Hansoh's pipeline layout to take shape and gradually bear fruit. Currently, Hansohn Pharma has7An innovative drug has been approved for marketing, these products have not only brought significant revenue growth but also optimized the company's revenue structure.

2024In the year, the sales revenue of Hansoh's innovative drugs and cooperative products increased year-on-year.38%To94.77billion yuan, accounting for approximately77%`, indicating that Hansoh has become a truly innovation-driven company.`

Now, with the approval and market launch of Aumetinib in the UK, it is set to become a new growth driver for revenue. Even larger markets await Aumetinib’s expansion, as its marketing application in the EU is currently under review. The independent overseas commercialization model established by Aumetinib is also expected to be continuously carried forward through Hansoh Pharma’s innovative system.

An increasingly rich product portfolio, steadily growing revenue from innovative drug businesses, and promising overseas markets have continuously strengthened Hansoh's self-sustaining capabilities, which in turn can support innovation and R&D. From the R&D end to the commercial end, Hansoh has successfully established a positive closed loop, setting a valuable example for the innovative transformation of traditional pharmaceutical companies.

Summary

Ameitinib's Approval for Marketing in the UK is Not an Accidental Success, but a Joint Achievement of Hansoh Pharma’s Internationalization and Innovation Transformation Strategy. This success not only confirms the rise of Chinese pharmaceutical companies in the global wave of pharmaceutical innovation, but also points out the direction of transformation for other traditional Chinese pharmaceutical enterprises.——Only by adhering to independent innovation, aligning with the highest international standards, and focusing on clinical value can one remain invincible in global competition.

Looking forward to seeing Chinese pharmaceutical companies achieve collective breakthroughs in internationalization in the future.

References

[1]The Road to the Development of Aumetinib: Originating from Design, Optimized in Both Directions | Words from the Researchers of Jiayan Meixing. Pleasant Lungs New Forest Official Account. 2020.

[2]Decision of the National Intellectual Property Administration on the Awarding of the 24th China Patent Awards.National Intellectual Property Administration. 2023.

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