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#7357

Asieris Pharmaceuticals Unveils 2023 Annual Report, Core Product APL-1702 Succeeds in Global Phase III Clinical Trials, APL-1706 obtains NDA acceptance domestically, Specialty Commercial Team Generates Sustained Revenue Streams

The company is gearing up to submit a market approval application for APL-1702 to China’s National Medical Products Administration (NMPA), with acceptance anticipated in the second quarter of 2024.

Looking ahead, the company plans to facilitate localized production and initiate development of a second-generation product for APL-1702. It also intends to submit a pre-NDA communication application to the European Medicines Agency (EMA) in the third quarter of 2024. Additionally, the company expects to be in discussions with the US FDA in second half of 2024 to align with the agency on the registration requirements in the US. It is also actively exploring opportunities for overseas development partnership for APL-1702.

APL-1706 is the only imaging agent approved worldwide for the diagnosis and surgical treatment of bladder cancer. APL-1706, in combination with BLC for managing non-muscle invasive bladder cancer (NMIBC), has been endorsed in the global expert consensus as well as in the Chinese guidelines for urological and andrological diseases. While not yet available in China, a market approval application for APL-1706 was accepted by the NMPA in November 2023. The company is progressing through the review process and anticipates an NMPA approval by June 2025.

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#7358

Wow!

The company is gearing up to submit a market approval application for APL-1702 to China’s National Medical Products Administration (NMPA), with acceptance anticipated in the second quarter of 2024.

Looking ahead, the company plans to facilitate localized production and initiate development of a second-generation product for APL-1702. It also intends to submit a pre-NDA communication application to the European Medicines Agency (EMA) in the third quarter of 2024. Additionally, the company expects to be in discussions with the US FDA in second half of 2024 to align with the agency on the registration requirements in the US. It is also actively exploring opportunities for overseas development partnership for APL-1702.

Må vel bli solide milestones søknad NDA US, Europa og Asia? Og deretter eventuelle enorme mulig summer i royalties når det snakkes world wide og aktivt søker mulighetsrom med partnere for 1702?

Og for 1706 forventer partner markedstilgang om ca ett år?! APL-1706 was accepted by the NMPA in November 2023. The company is progressing through the review process and anticipates an NMPA approval by June 2025 .

5 Likes
#7360

Enig helt storartet! Og liker cashbeholdingen! Og liker samarbeidet Photocure sin partner har med Sinopharm (statlig knyttet og prinsippet utømmelig lommebok?)

SHANGHAI, April 17, 2024 /PRNewswire/ – Asieris Pharmaceuticals today released its 2023 Annual Report, revealing impressive outcomes achieved through its specialty pharma strategy, which has facilitated rapid progress in clinical development, early research, and commercialization. Asieris boasts a robust pipeline now consisting of 13 products and 16 ongoing research projects. By the end of 2023, cash and cash equivalents along with financial assets held for trading totaled approximately RMB 2.333 billion, ensuring ample capital reserves for sustainable growth.

Multiple Assets Achieved Clinical Milestones, Paving Way for New Products Launch

#7361

Kan være lov å håpe på enda litt mer oppdatert info i Q1-rapporten som kommer allerede 24/4.

1 Like
#7362

Stusser litt på den meldingen.

Er det bare godkjent, som akseptert søknaden. Eller snakker vi faktisk godkjent for salg?

Rart hvis Cevira som ikke er sendt inn til godkjenning enda, plutselig kommer på markedet mye tidligere en Hexvix, som ble levert søknad på i fjor…

#7363

Godkjent som i akseptert søknad inntil noe annet et bekreftet.

Cevira er nok mer aktuell for Fast Track, og halmstrået i CMA, enn Hexvix. Men samme som over, ta utgangspunkt i 18 mnd godkjenningstid inntil noe annet eventuelt er bekreftet.

3 Likes
#7364

Cash inn i Q2 da for akseptert søknad NDA, milestone utbetaling?

Spennende fast track i Kina. KAN det være at det oppnås fast track?

https://english.news.cn/20240207/4ab3db9a634047d28f487168bad55351/c.html

China New Growth: Boao Lecheng pilot zone explores fast track into China’s medical market

Source: Xinhua

Editor: huaxia

2024-02-07 20:41:30

By Xinhua Writers Cheng Yunjie, Cui Enhui, Zhong Qun, Wu Maohui and Chen Kaizi

HAIKOU, Feb. 7 (Xinhua) – Normally it would take three to five years for a foreign medical product or device to enter China’s market, but in Lecheng, the country’s only special medical zone on the southern tropical island of Hainan, the process takes just a few months.

A typical example is the Rezūm System from Boston Scientific, an innovative minimally invasive therapy designed to treat the symptoms of benign prostatic hyperplasia. Through the pathway supported by real world evidence, it took approximately four months for the company to complete the application and approval procedures, more than two and a half years quicker than the conventional pathway, and the therapy has been applied in more than 100 Chinese hospitals.

So far more than 370 original new overseas pharmaceuticals and medical devices from over 130 companies in 17 countries have been put to pilot use in Lecheng, as they are of clinical urgency and cannot be replaced by alternatives that are already available. The new pharmaceuticals and medical devices cover 28 disciplines including ophthalmology, otolaryngology, cardiology and rehabilitation.

In addition, 13 medical products and devices have been approved for sale in the Chinese market thanks to the use of real world data as an auxiliary means of clinical assessment, according to the pilot administration.

A PATHWAY LIKE NO OTHER

Jia Ning, director of the pilot zone administration, said the introduction of the new approval pathway in 2019 has raised the city’s profile.

“Lecheng has had higher visibility in the industry,” he said. “We have established a very important and unique pathway for international innovative medicines and medical devices to quickly enter China.”

Og hvem er i denne pilot zone administration? Asieris!

Asieris Pharmaceuticals is also making solid progress in commercialization by building an end-to-end team: from marketing, sales, commercial operations, market access, integrated operation of diagnosis and treatment, to sales efficiency. We have also launched related products in Hainan Province’s Bo’ao Lecheng National Pilot Zone of International Medical Tourism.

On 20 May 2021, Asieris Pharmaceuticals and Sinopharm Group signed a strategic collaboration agreement for launching innovative pharmaceutical and device products in Bo’ao Lecheng. As a result, selected Chinese patients had early access to APL-1706, which also subsequently received approval in March 2022 by the CDE to be included in the real-world clinical data pilot program.

1 Like
#7365

En bruker her market approval application og ikke NDA hva er forskjellen og betyr det at de går for market approval direkte? Kan det bety fast track eller emergecy approval eller noe lignende?

Lurer og på om Photocure greier å få ut en melding på dette før åpning i morgen?

#7366

Det jeg ble litt usikker på. Da det plutselig ble brukt andre betegnelser.

Men ser ikke hvorfor Photocure trenger sende melding. Kom ikke noe ny info. Allerede kjent at dem håpte på søknad iløpet av Q2 :man_shrugging: Ble vel allerede nevnt på meldinger fra Asieris når dem møtte kriteriene, og igjen ved fremføring av resultat.

#7367

Dette er nytt;

2 Likes
#7368

Asieris Pharmaceuticals Unveils 2023 Annual Report, Core Product APL-1702 Succeeds in Global Phase III Clinical Trials, APL-1706 obtains NDA acceptance domestically, Specialty Commercial Team Generates Sustained Revenue Streams

Shanghai, China, April 17, 2024 – Asieris Pharmaceuticals today released its 2023 Annual Report

Ganske så stilig med headingen

……CORE PRODUCT APL-1702 succeeds in….
CORE

Cevira er core asset. Hva betyr en slik statement??

Og kan Lecheng området Asieris og Lecheng Sinopharm operere i ha etablert rask godkjennelse for Cevira i Q2 2024?

#7369

Intend, plan, expect… med andre ord, ingenting håndfast.

Send melding når det faktisk skjer. Annet er bare vissvass.

Må få plukket ned noen av disse “fruktene” som allerede er i spill.

#7370

Ja vi må nok vente på en børsmelding i Q2 2024…
Og Q2 2024 er vi inne i….

Det komiske er at veldig mange her er misfornøyd med at selskapet ikke melder nok (og altfor lav kurs) også om tidslinjer…her er det mye damn if you do and damn if you don’t :sweat_smile:

Mye fin og ny info her. Og linjene må følges opp. Klart det. Regner med noe mer detaljer ved neste Q rapport
Apr 25, 2024

(03/2024)

#7371

Aha, så det er du som bidrar til å stoppe enhver oppgang :wink:

Selv håper jeg alle tradere som vanlig selger seg ut etter en bitteliten oppgang og blir stående igjen på perrongen når den ordentlige oppgangen kommer :grinning:

2 Likes
#7372

Ja, det har sannelig tatt 5 år med Hexvix. Går fortere med Cevira som har gjennomgått phase III i Kina.

1 Like
#7373

Om det er aktuelt, følger ikke Photocure like nøye hva som skjer i Kina som det vi gjør… :thinking:

2 Likes
#7374

Jeg vet ikke om disse resultatene har kommet klart frem i pressemeldingene fra Photocure.
Dette utkaste fra meldingen fra Asieris i går;

In September 2023, APL-1702, a combination of drug and medical device designed for photodynamic non-surgical treatment of cervical high-grade squamous intraepithelial lesions (HSIL), met its primary endpoint in the international multi-center phase III clinical trial. Results showed that the APL-1702 treatment group had a significantly higher response rate on the primary efficacy endpoint, with a response rate 89.4% higher than the placebo group (41.1% vs. 21.7%, p = 0.0001). Additionally, APL-1702 demonstrated a 103.9% improvement in the clearance rate of high-risk HPV16 and/or HPV18 compared to controls (31.4% vs. 15.4%). APL-1702 also showed low incidence of treatment-emergent adverse events. These findings were featured in oral presentations at the 2024 European Research Organization on Genital Infection and Neoplasia (EUROGIN) Congress and the 2024 Society of Gynecologic Oncology (SGO) Annual Meeting.

Hva er det Asieris vil her med Cevira;

Looking ahead, the company plans to facilitate localized production and initiate development of a second-generation product for APL-1702.

#7375

Da kan du jo begynne med å lese pressemeldingene til Pho?

https://newsweb.oslobors.no/message/613693

In terms of the primary efficacy endpoint, the response rate in the APL-1702 group was significantly higher than that in the control
group, with an increase of 89.4% (41.1% vs. 21.7%, p = 0.0001), which isconsidered a highly clinically relevant effect.

Additionally, APL-1702 showed an improved clearance rate of high-risk HPV16 and/or HPV18, with a 103.9% increase in the APL-1702 group compared to the control group (31.4% vs. 15.4%).

The incidence of treatment-emergent adverse events (TEAEs) was comparable
between the APL-1702 group and the control group, with the majority being mild
and self-resolving without requiring intervention.

The occurrence rates of
treatment-related adverse events (TRAEs) and serious adverse events (SAEs) were
low in both groups.

#7376

Det jeg tenkte på var de % 89,4% og 103,9% compared to control group, men det kom klart frem i meldingen til Photocure. Beklager men gode ting kan ikke sies ofte nok.

#7377

Aksjemarkedet er fullt av paradokser.

I PHO med solid økonomi, flere triggere det virkelig kan smake fugl av og ambisiøse samarbeidspartnere, her er det et totalt fravær av interesse, av kjøpere.

Selv i ULTI som sliter med både armer og bein, og der man risikerer å bli raukjørt for andre gang på kort tid etter “Det store fallet som hjemsøkte norsk biotek”, ja selv der er omsetningene på bøsset som ligger igjen fem-seks ganger høyere enn i PHO.

Nå er det vel ikke helt ufortjent at PHO har havnet litt i glemselen. Selskapet har jo vært hardt rammet av TING TAR INNMARI LANG TID-syndromet. Men nå som det ser ut til å løsne, er interessen verken til å ta eller føle på. Her er det åpenbart en jobb å gjøre.

En litt hårete målsetting kunne vært at Xi på neste partikongress stiller med en PHO-button på jakkeslaget.

Alternativt et tettere samarbeid med Asieris rundt kommunikasjonen utad om de begivenhetene som angår begge selskap.
Det er tungvint at dyktige aksjonærer må dypdykke rundt i nettet for å få bekreftet de lyse utsiktene dette samarbeidet vil gi.
Her trengs det en info-offensiv a la Make Photocure Great Again.

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