In womenâs health, APL-1702, a combination of drug and medical device designed for photodynamic non-surgical treatment of cervical high-grade squamous intraepithelial lesions (HSIL), is making steady progress toward market approval. In May 2024, the productâs marketing application was officially accepted by the National Medical Products Administration (NMPA). As of the reportâs release, the Center for Drug Evaluation (CDE), NMPA had completed the first round of technical reviews, covering toxicology, clinical data, biostatistics, clinical pharmacology, and pharmaceutical quality. During the reporting period, the Inspection Center also wrapped up its Good Clinical Practice (GCP) inspection. The company has since received written feedback and is actively coordinating its responses to help expedite the review process and bring APL-1702 one step closer to approval.
As a first-in-class treatment set to debut in China, APL-1702 is on track to become the worldâs first non-invasive therapy for HSIL â supported by robust clinical evidence and validated through an international Phase III trial. Experts note that, with China facing demographic pressures and a rising incidence of cervical intraepithelial neoplasia (CIN) among younger women, surgical excision of the cervix poses increasing challenges â especially during the critical period of fertility preservation. APL-1702 is expected to bridge this critical treatment gap and contribute to the creation of a more fertility-friendly healthcare landscape.
To drive the commercialization of APL-1702, the company has hosted eight expert advisory meetings, focusing on Phase III clinical data, the current landscape of HSIL diagnosis and treatment, and unmet clinical needs. These sessions earned strong endorsement from leading gynecological and pharmaceutical experts, who recognized the innovation and clinical value APL-1702 brings to the table. The company has also made meaningful progress in building strategic partnerships with government agencies and leading academic associations. In collaboration with the Cancer Foundation of China, the company unveiled the first real-world showcase of its innovative cervical cancer prevention and control system at the 7th China International Import Expo (CIIE). It also signed medium- to long-term strategic cooperation agreements with both the China Womenâs Development Foundation and the Cancer Foundation of China during the event. The partnerships are set to roll out in 2025.
The Womenâs Health Division has conducted extensive market and industry research, gaining deep insights into the needs of doctors and patients and broader commercial landscape. Based on this analysis, the team has finalized key launch strategies and mapped out a commercialization roadmap, laying the groundwork for a swift market rollout once approval is secured.
Given the relative scarcity of innovation in the gynecological field, APL-1702 stands out as a meaningful breakthrough, backed by solid clinical evidence and proven efficacy. The company will continue to prioritize APL-1702 and its photodynamic drug-device combination platform, in a bid to build a comprehensive, tiered gynecological portfolio. This strategy will center on product iteration and indication expansion, while leveraging synergies across the pipeline to drive broader growth.
Med andre ord kommer ikke godkjenningen pÄ mandag. Realistisk med godkjenning i juni/juli?
the company received feedback from its communication meeting with the U.S. FDA in December 2024, culminating in an agreement on a new Phase III clinical design to support the U.S. launch of APL-1702. Asieris is now actively seeking international partners to advance the U.S. Phase III clinical trial application. Additionally, APL-1702 is also being investigated for its potential in HPV virus clearance.
Helt utrolig hvor trege de kineserne er. 
Hvad begrunder du det med at der pludseligt skal gÄ sÄ lang tid efter den er gÄet ind i den sidste evaluering 20. februar og ifÞlge NMPAs egne procedure skulle tage max 30 arbejdsdage. (Godkend 4.april)
TÊnker her om det mere er et hÄb fra din side om godkending mandag eller ??? 
Dansken
De har fÄtt skriftlig tilbakemelding de mÄ respondere pÄ. Det kan vÊre spÞrsmÄl, avklaringer, presiseringer eller krav til ytterligere dokumentasjon. Ikke uvanlig, spesielt for nye produktkategorier som Cevira.
Det betyr at sÄ fort Asieris responderer tar det noen dager fÞr NMPA utfÞrer gjennomgangen, og eventuelt gir endelig svar pÄ sÞknaden. Tar fort +/- 30 arbeidsdager. Kommer an pÄ prioriteringen.
Jeg tolker det slik at de allerede har gitt tilbakemelding, og at endelig svar kan komme nĂ„r som helst.! Videre er det litt spesielt at myndighetene krever "tilbakemelding " sĂ„ sent i prosessen, noe som ikke stemmer med stegene i NMPA prosedyrer, for godkjent/ikke godkjente medesiner/behandlingâŠ
Er dette fra Ă„rsrapporten?
I sÄfall er dette ting som har skjedd fÞr 31.12.2024
Denne tilbakemeldingen kan jo vĂŠre gjort og avklart for god tid siden, og at godkjenningen dermed kan vĂŠre rett rundt hjĂžrnet.
Hm, kan kanskje vÊre avklart «allerede». Og sÄ er spÞrsmÄlet om noen av nyansene gÄr tapt i oversettelsen. I alle tilfelle er det viktigste at de har kontroll og har forsert de viktigste tersklene (review av de ulike sÞknadsbestanddelene og inspeksjoner). Ikke om det er pluss-minus noen uker. God pÄsk 
Liker denne spesielt godt:
âThe Womenâs Health Division has conducted extensive market and industry research, gaining deep insights into the needs of doctors and patients and broader commercial landscape. Based on this analysis, the team has finalized key launch strategies and mapped out a commercialization roadmap, laying the groundwork for a swift market rollout once approval is secured.â
Ja, fra Ă„rsrapporten. Men fra Q3-rapporten som kom 27 Februar hvis jeg husker rett, hadde oppdatering rundt sĂžknadsprosessen for Cevira (tekniske reviews utfĂžrt). Det vet vi skjedde 20 Februar, ref. linken med lyspĂŠrene.
Det er altsÄ fersk informasjon slik jeg tolker det. Spesielt nÄr de skriver:
Det var i alle fall ikke noe negativt Ă„ spore i denne rapporten. For alt vi vet dreide den nevnte tilbakemelding seg kanskje bare om mer bagatellmessige momenter. Klarer ikke Ă„ spore et snev av pessimisme her!
I sÄfall kan det snakk om fÄ dager, og ikke en helt ny gjennomgang av prosessen (30 dager)
Avslag, sÄ er det toppen av kransekaka for norsk bio 
Som flere skribenter skriver kan det vÊre tidligere henvendelser som Asieris har svaret pÄ.
Syntes at huske at den sidste 30 dages evaluering ikke skulle mangle nogle informationer
Ănsker snart ventetiden er ovre for afklaring
Godkendt/afslag 
Dk
Da blir det all-inn SoftOx 
Hvis du husker igjen pollen sÄ er vi jo ganske mange her som har trodd meldingen kommer senere i Är da.
Det faktiske forhold er vel slik at kineserne har vist at de er raske med regulatoriske forhold. Imponert over myndigheter og partner Asieris. Her diskuteres det om Photocure fÄr fram et produkt i markedet. I sÄ fall en enorm bragd og historisk i sÄ fall for norsk biotek. At noen mener det er krise med noen uker eller et par mÄneder fÞr avklaring er i mine Þyne helt irrelevant. Kan like gjerne plutselig komme melding fra myndigheter her. Helt umulig Ä si med sikkerhet.
Positivt med Hexvix
The Oncology Business Unit is fine-tuning the launch strategy for HexvixÂź, initially targeting patients with commercial insurance or those willing to pay out-of-pocket. The early rollout will cover the special and international medical departments of top-tier hospitals in major cities, as well as premium foreign-invested and private urology specialty hospitals. As clinical guidelines are released and endorsements from leading urology experts are established, the launch will be paired with the introduction of disposable blue light cystoscopes. Together, these efforts aim to accelerate the adoption of blue light cystoscopy in general hospitals and foster an integrated approach to the diagnosis and treatment of bladder cancer.
Interessant med U.S. HPV virus clearance. APL 1702
In the fields of womenâs health, breast cancer, and gynecological tumors, Asieris has made remarkable progress. Building on the strong results of the international multicenter Phase III study of APL-1702, the company received feedback from its communication meeting with the U.S. FDA in December 2024, culminating in an agreement on a new Phase III clinical design to support the U.S. launch of APL-1702. Asieris is now actively seeking international partners to advance the U.S. Phase III clinical trial application. Additionally, APL-1702 is also being investigated for its potential in HPV virus clearance.
Our pipeline is entering a critical sprint toward market launch and is set to power the next wave of performance growth. While reinforcing our commercial capabilities, weâre also accelerating clinical programs with a strategic focus on womenâs health and urological oncology. Weâre building a robust pipeline of first-in-class and highly-differentiated fast-follow therapies, while actively expanding into global markets to unlock the full value of our assets.
SÄ feedback og svar til CDE kan ha blitt sendt nÄr som helst mellom 27 Februar og i dag da, om en tenker (litt konservativt) denne feedbacken og svar kom rundt de 30 dagene det var snakk om (4.April), og nye 30 dager etter det, sÄ blir det ca. midt i Mai?
Regner egentlig med det kan bli alt fra Mandag til ut i Juni, spennende uansett. 
Konservativt? Det vil vÊre Ä anta at svar ikke er sendt inn p.t. Teksten kan tolkes som at de holder pÄ med responsen.