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Guojin Securities: Sevotinib hits an inflection point in value and begins global commercialization in '27
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The Zhitong Finance App learned that Guojin Securities released a research report saying that sevolitinib will turn excellent data into an important milestone inflection point in commercial sales growth. In the short term, the bank continues to be optimistic about the two major research data catalysts that ESMO will release; in the medium to long term, the bank is also optimistic that the drug will simultaneously usher in an inflection point in commercialization growth in domestic and foreign markets. Based on the above analysis, Syvetinib Equity Party and Huang Pharmaceutical (00013) were given a “buy” rating.

Guojin Securities's main views are as follows:

The MET targeted drug circuit accelerates iteration, and sevolitinib leads the card position

MET gene abnormalities include MET-ex14 jump mutations, MET activation mutations, MET gene amplification, MET gene fusion, and MET protein overexpression. Among them, patients with MET gene amplification and MET protein overexpression have a large base. Among them, the gold standard for detecting MET gene amplification in MET gene abnormalities is FISH; however, MET protein overexpression relies on IHC immunohistochemical testing. Historical studies have shown that the proportion of MET gene amplification positive (FISH test, GCN≥5 and/or MET/CEP7≥2) occurs after EGFR-TKI progresses, and the desire for a second biopsy in such patients is about 40%-50%; however, overexpression of C-MET protein is one of the factors that induce cancer, of which high expression accounts for about 1/3 of NSCLC. Compared to MET-targeted drugs, they are divided into three categories: small-molecule METTKI (such as Zevotinib from Hewang Pharmaceutical/AZ), anti-MET antibody/double antibodies (such as J&J's evantumab), and C-METADC (such as AbbVie's abbV-400). Small molecule MET-TKI is currently the mainstream clinical drug.

2LEGFRMT/Metamp welcomed a key breakthrough. Sevotinib announced global clinical results at ESMO with the highest specifications

EGFR mutations are one of the biggest factors in gene mutations in NSCLC patients. In 2025, global sales of EGFR-TKI (EGFR-TKI) alone have reached 7.254 billion US dollars, of which 3/4 is expected to be the 1L market. After EGFR-TKI resistance, it is a huge market, with MET gene abnormalities accounting for a large proportion. The bank estimates that the 2L treatment EGFRMT MET amplifies NSCLC neutral prediction market size of about 700 million US dollars. Early diagnosis and treatment of 2legFRMT/metAMP NSCLC is relatively empty, but the current treatment pattern is becoming more clear: CSCO (China Authoritative Guide) and NCCN (American Authoritative Guide) are putting more emphasis on MET amplification testing. Among them, CSCO has upgraded the MET amplification test from level II recommendation to level I in 2026, accompanied by the emergence and popularity of MET-targeted drugs -- savotinib, as the only drug that has achieved phase III clinical success in this indication, will be marketed in China and globally, and is expected to maintain a long period of exclusive commercialization. Three studies were arranged around 2LEGFRMT/MET amplification of NSCLC, and Huang Pharmaceutical/AZ: SACHI-China Phase III Study (published results, ITT MPFS=8.2mO vs. 4.5mo, HR=0.34; MOS=22.9mO vs. 17.7mo, HR=0.84); SAVANNAH - Global Phase II Clinical (published results, ITT MPFS=7.4mO, Asian MPFS=7.6mO); SAFFRON - Global Phase III Study (MPFS=7.6mO vs. 5.4mo, HR=0.55; MOS=17.8mO vs. 12.9mo, HR=0.68), the efficacy of sevolitinib was prominent in this group of patients.

1legFrmt/Met overexpression of nsCLC does not meet high clinical demand, and sevotinib will maintain monopoly for a long time

Currently, there is no clear and independent diagnosis and treatment path for NSCLC expressed by EGFRMT/Met in the relevant guidelines, so there is a huge unsatisfied market in this market. Savotinib is expected to become the first marketed drug in the market — its registered phase III clinical results will be announced in LBA form on October 26, 2026 (MPFS=24.8mO vs. 11.1mo, HR=0.45; mOS = 44.5movs.34.9mO, HR=0.48), and Chewang Pharmaceutical plans to submit a marketing application for new indications of savotinib for first-line treatment in China at the end of 2026.

Breaking through the single indication ceiling, the second curve drives the explosive growth of sevolitinib at home and abroad

Sevotinib not only has data catalysts in ESMO — both data were released in LBA's high-specification format, but more importantly, sevolotinib also turned excellent data into an important milestone inflection point in commercial sales growth: Looking back on history, in the past, sevolotinib was stuck in the MET-Ex14 transition to the NSCLC Red Sea market, and sales were mediocre; however, starting in '27, the drug is expected to usher in explosive growth: ① Domestically, 2legfrmt/MetAMP NSCLC was expressed by AZ in '26 NSCLC will announce the final results of the Phase III registration study - SANOVO on October 26, 2026. Subsequently, Hehuang and AZ are expected to push for NDA submission for this indication as soon as possible. ② Overseas, AZ submitted an NDA for 2legfrmt/metamp NSCLC indications to the FDA on September 29, 2026. ③ The new indications all use the combined osidinib scheme, which will improve the sales ecosystem of the large AZ product osimitinib and extend the life cycle of osimitinib, thus greatly mobilizing AZ's enthusiasm to promote commercial sales of sevotinib.

Risk Alerts

The detection rate for MET gene abnormalities falls short of expectations, the risk of worsening competition, clinical data falling short of expectations, health insurance negotiations falling short of expectations, and marketing progress falling short of expectations.

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