Investor questions:
I would like to ask if 1702 has already issued a supplement and whether there is any cooperation between 1702 and the National Health Commission’s cervical cancer elimination plan? Can you disclose the details?
The secretary of the board of directors answered ( Yahong Pharmaceutical( 9.540 , 0.04 , 0.42% ) SH688176):
Dear investors, hello! The company has recently submitted supplementary materials to the Drug Evaluation Center of the State Drug Administration, and will accelerate its market review and approval work. At the 7th China International Import Expo held in 2024, the company cooperated with the China Cancer Foundation to promote the first real-life exhibition of the innovative prevention and control system for accelerating the elimination of cervical cancer. APL-1702 was highlighted and reported as an innovative product of “global debut and China’s first exhibition”. At the same time, the company has carried out a series of substantive promotion work in seeking strategic cooperation with government departments and relevant academic associations, and signed a medium- and long-term strategic cooperation agreement with the China Women’s Development Foundation and the China Cancer Foundation. In 2024, the company successfully held 8 expert consultation meetings on key topics such as the Phase III clinical data of APL-1702, the diagnosis and treatment status of HSIL, and clinical needs, and won the recognition of gynecological experts and pharmaceutical experts for the innovation and clinical value of APL-1702. Experts believe that under the new demographic situation in my country, the onset of the disease is becoming younger and the treatment status is mainly based on cervical resection surgery, which brings new challenges to the management of cervical precancerous lesions in the important window period of “fertility protection”. APL-1702 is expected to fill this clinical treatment gap and help build a fertility-friendly society. Thank you for your attention.
Yahong Pharmaceuticals announced on June 13 that on June 12, the company received Huayuan SecuritiesWe received research from several institutions including Yang Mingyuan, Secretary of the Board of Directors and Chief Financial Officer, and Chen Juan, Director of Investor Relations. The reception was held in the company’s conference room.
Chat GPT oppsummering av hovedinnholdet og det som er relevant for APL-1702:
Status for godkjenning
Asieris bekrefter at:
«APL-1702 ble sendt inn til NMPA i mai 2024, og i juni 2025 ble tilleggsdokumentasjon (Supplementary Information) sendt inn til CDE.»
De sier at de vil akselerere prosessen for godkjenning , men ingen konkret tidsangivelse er gitt.
Markedsstørrelse
- I Kina finnes det anslagsvis 2,1 millioner kvinner over 18 år med HSIL (High-Grade Squamous Intraepithelial Lesions).
- Pasientgruppen forventes å vokse i løpet av de neste 10 årene.
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Omtrent 50 % av pasientene behandles i offentlige sykehus av høyeste kategori (tredjenivå-sykehus).
Kommersialiseringsstrategi
Asieris har iverksatt bredt anlagt forarbeid for lansering:
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Markedstilgang og refusjon : Strategiske dialoger og politikkpåvirkning er i gang.
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Retningslinjer og ekspertstøtte : Samarbeid med kliniske eksperter og arbeid for å integrere behandlingen i kliniske guidelines.
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Treningsprogrammer for leger og informasjonskampanjer mot offentligheten.
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Rekruttering av salgsteam og oppbygging av en flerdimensjonal distribusjonskanal.
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Leveringskjedeoptimalisering for å sikre umiddelbar tilgjengelighet etter godkjenning.
Produktets unike posisjon
- Det omtales som verdens første produkt med positivt fase 3-resultat for HSIL i en internasjonal multisenterstudie .
- Produktet fremheves som en ikke-invasiv behandling, i kontrast til kirurgiske alternativer.