Hansoh Pharma Announces First Overseas Approval of China-Originated EGFR-TKI Aumseqa in the UK

6Month4Day,Hansoh PharmaAnnounced that its innovative drugAlmonertinib Mesylate Tablets(UK product name:Aumseqa）ObtainUK Medicines and Healthcare products Regulatory Agency（MHRA）Approved for marketing as a single-agent treatment for adults with locally advanced or metastaticNon-Small Cell Lung Cancer（NSCLC）And has activated epidermal growth factor receptor（EGFR）First-line treatment for patients with mutations, and adult locally advanced or metastaticEGFR T790MMutation-PositiveNSCLCPatientTreatment.

According to the news release from Hansoh Pharma, Aumetinib Mesylate Tablets have become the first innovative drug approved for entry into overseas markets by Hansoh Pharma, as well as the first China-originated drug to be launched abroad.EGFR-TKI。

Original Research Third GenerationEGFR-TKI

Almonertinib is the first third-generation epidermal growth factor receptor tyrosine kinase inhibitor developed by Hansoh Pharma in China and the second approved globally.（EGFR-TKI）, through specific inhibitionEGFRSensitive Mutation(such as exons19Missing,L858RReplacement)AndT790MDrug resistance mutations, blocking tumor cell proliferation signaling pathways, while inducing cancer cell apoptosis.

This timeMHRAApproval is based on data from two pivotal clinical trials:Registered in China respectivelyPhase Ⅲ TrialAPOLLOResearch, the results show that for the first generation/Second GenerationEGFR-TKIAfter Drug ResistanceT790MMedian Progression-Free Survival of Aumolertinib in Mutation-Positive Patients（mPFS）Reach12.3Months, Objective Response Rate（ORR）For68.9%, significantly superior to chemotherapy. As well as global Phase III trialsAENEASResearch, the results show that in the first-line treatmentEGFRSensitive MutationNSCLCIn China, AumetinibmPFSAchieve19.3months, extending longer than the first-generation drug Gefitinib9.4months, and the efficacy is significant in patients with central nervous system metastases.

Previously，AlmonertinibFour indications have been approved for marketing in China, respectively: second-line treatment for patients who have previously receivedEGFR-TKITreatment progress, andT790MMutation-positive locally advanced or metastaticNSCLCPatient: First-line treatment hasEGFRExon19Missing or Exon21（L858R）Positive for substitution mutations, locally advanced or metastaticNSCLCAdult patients; unresectable locally advanced disease without progression after platinum-based radical chemoradiotherapyEGFRExon19Missing or Exon21（L858R）Substitution MutationNSCLCPatient treatment; and forⅡ-ⅢBPeriod HasEGFRExon19Missing or Exon21（L858R）Adults with substitution mutationsNSCLCThe patient's treatment requires that the patient has previously undergone surgical resection and, as determined by the doctor, may or may not receive adjuvant chemotherapy.

Competitive Landscape

EGFRThe mutation is non-small cell lung cancer（NSCLC）The main type of driver gene mutation, global third generationEGFR-TKIThe market size is expected to continue expanding.2020Year ChinaEGFRThe Targeted Drug Market Size is65.2100 million yuan, expected2030Year will reach395Billions, the proportion of third-generation drugs exceeds80%。

AstraZeneca's Osimertinib as the world's first third-generationEGFR-TKI，2023Global sales reached in year57.99Billion USD, Sales Revenue in the Chinese Market52100 million yuan, accounting forEGFR-TKIMarket41%Share. But Almonertinib in efficacy(such as postoperative adjuvant therapyDFSRate), safety (lower risk of interstitial pneumonia), and price, forming a differentiated advantage over Osimertinib. This time, the indication for which Aumolertinib was approved in the UK is completely consistent with Osimertinib, and it will compete with Osimertinib in the international market.

2024Annual Ametinib Hospital Channel Sales Nearly18billion yuan, a year-on-year increase of43.7%, with a significantly higher growth rate than Osimertinib.

In China, Ameitinib has two competitors, which are Furuomatinib from Allist and2024Annual sales are expected to exceed20100 million yuan,2025The growth rate in the first half of the year exceeded50%, becoming a "dark horse" among China-produced third-generation drugs. Additionally, Betta Pharmaceuticals' Befotini, with a price close to Aumolertinib and Furmonertinib, is expected2025Annual sales reached10-15100 million yuan. However, compared with the other two products, Aumetinib has a wider range of indications.

Facing increasing competitive pressure, Hansoh Pharma is developing the fourth generationEGFR-TKI（HS-10375）、EGFR/c-MetDual Antibody（HS-20117）AndADCDrug（HS-20093）etc.

1. Official WeChat Account of Hansoh Pharma