Hansoh Pharma's Aumolertinib Breaks Into Postoperative Adjuvant NSCLC Treatment Market

On July 19, the marketing application for the first domestically developed third-generation EGFR targeted drug, Hansoh Pharma's Aumolertinib, for adjuvant treatment of lung cancer after surgery, was accepted by the National Medical Products Administration (NMPA), drawing industry attention.

According to the latest statistical data released by the National Cancer Center, the number of new lung cancer cases in China reached 1.0606 million in 2022, ranking first among all cancer types; the number of deaths from lung cancer reached 733,300, nearly the total of the second, third, and fourth ranked cancer types combined. Moreover, whether in men or women, lung cancer is the leading cause of cancer-related deaths in China.

　　High Demand for Adjuvant Therapy in Lung Cancer Patients After Surgery

The mortality rate of lung cancer remains high, largely because the early symptoms are not obvious, and about 80% of lung cancer patients are diagnosed at middle or late stages. In recent years, with the improvement of public health awareness and advances in early diagnostic technologies, the early diagnosis rate of lung cancer has improved. However, what remains frustrating is that even if patients with early-stage lung cancer undergo complete surgical resection, the risk of recurrence and metastasis is still relatively high.

Data Show: The 5-year recurrence rate for stage ⅠB lung cancer patients is 45%, for stage Ⅱ it is 62%, and for stage ⅢA it is as high as 76%; if no postoperative adjuvant therapy is received, over 50% of lung cancer patients will experience recurrence or metastasis within 5 years, with approximately 74% experiencing distant metastases post-surgery, primarily brain metastases. Once distant metastasis occurs after surgery, the impact on patient prognosis is more severe, and subsequent treatment becomes even more challenging. Currently, the 5-year survival rate for stage ⅠB-ⅢA lung cancer patients in China is only 36% at its lowest, still far from the goal proposed by the National Health Commission of "achieving a 46.6% 5-year cancer survival rate by 2030," indicating significant room for improvement. Therefore, postoperative adjuvant therapy is crucial for early-stage lung cancer patients.

If we roughly estimate that 20% of lung cancer patients are in the early stage, China sees about 212,000 newly diagnosed early-stage lung cancer patients each year. Adding existing patients, the total number may reach a million. Moreover, post-surgical adjuvant therapy requires long-term or even lifelong treatment, indicating a significant market demand.

　　Targeted Therapy May Become the Mainstream Approach for Adjuvant Treatment After Lung Cancer Surgery

Currently, the main postoperative adjuvant treatment methods for lung cancer include postoperative adjuvant chemotherapy, radiotherapy, targeted therapy, and immunotherapy, etc. Although traditional treatment methods such as postoperative adjuvant chemotherapy can improve patients' overall survival (OS) and disease-free survival (DFS), the benefits to patients are limited: for example, in patients with early- and mid-stage non-small cell lung cancer, the 5-year OS rate increases by only about 5%. Moreover, the incidence of adverse reactions from chemotherapy is high, making it difficult for patients to tolerate and significantly affecting their quality of life.

Unlike adjuvant chemoradiotherapy, targeted adjuvant therapy can specifically act on certain specific sites of tumor cells, highly selectively killing tumor cells without harming or causing minimal damage to normal cells. It shows significant clinical benefits and is a treatment method prioritized and recommended by authoritative guidelines both in China and internationally.

It can be foreseen that targeted therapy will become the mainstream approach in adjuvant treatment after lung cancer surgery.

　Ameitinib Will Again Lead the Innovation of Chinese Production

In China, 40% of lung cancer patients have non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) gene mutations. This proportion is 2 to 3 times higher than in European and American countries, indicating a significant clinical demand for EGFR-targeted drugs in China.

The data in the research report also confirms this point. According to Guosen Securities, the sales revenue of EGFR-targeted drugs in China exceeded 10 billion yuan in 2022; according to Frost & Sullivan's forecast, by 2030, the market size of EGFR-targeted drugs in China will reach 60.2 billion yuan.

The market capacity is often directly proportional to the intensity of competition, and the competition for EGFR-targeted drugs in China is nearly at a fever pitch. Currently, EGFR-targeted drugs approved for marketing in China are divided into first, second, and third generations, with third-generation targeted drugs dominating the market, accounting for approximately 70% of the total share. The third-generation targeted drugs also represent the most fiercely competitive subcategory, with as many as six third-generation EGFR-targeted drugs approved for marketing in China, five of which are domestically produced.

Among the five China-produced third-generation EGFR targeted drugs approved for marketing, Hansoh Pharma's Almonertinib took the lead: In March 2020, Almonertinib was approved for patients with locally advanced or metastatic NSCLC who had progressed after prior EGFR-TKI treatment and were positive for the T790M mutation, becoming the first China-produced third-generation EGFR targeted drug to be approved for marketing; In December 2021, Almonertinib was approved as a first-line treatment for adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, making it the first China-produced third-generation EGFR targeted drug approved for first-line indications. Notably, both first-line and second-line indications have been included in the National Medical Insurance Catalog.

With the first-mover advantage and the support of China's national medical insurance, Aumetinib quickly gained market share after its launch, consistently ranking first among China-produced third-generation EGFR targeted drugs. However, with the continuous expansion of China-produced third-generation EGFR targeted drugs and the high overlap of indications among various products, Aumetinib is exploring new battlegrounds to secure broader market growth opportunities.

Postoperative adjuvant therapy is precisely such a new market with immense growth potential and imaginative possibilities — large market capacity and relatively few competing products. Currently, Osimertinib is the only drug approved for this indication. Once Almonertinib receives approval, it is expected to become the first domestically produced third-generation targeted drug approved for postoperative adjuvant therapy, being the pioneer among Chinese third-generation EGFR targeted drugs to tap into this blue ocean of postoperative adjuvant treatment. Even if other domestic third-generation EGFR targeted drugs also enter this indication area, Almonertinib can still leverage its first-mover advantage to secure the most advantageous position in future competition.

For Chinese lung cancer patients who require postoperative adjuvant treatment, the introduction of Aumolertinib will also provide them with a new treatment option, significantly enhancing drug accessibility. This is undoubtedly a win-win and beneficial piece of news.