Diskusjon Triggere Porteføljer Aksjonærlister

Photocure småprat (PHO) 🔦 3

Ja – men de har da ikke “opfundet produktet” – det er da tyveri af ophav !!

Dansken

Partneravtale med milestones og royalties.
Samarbeidsavtale som ellers i biotek. Synes som Photocure har vært riktig så dyktig med valg av partner! Eller dyktighet og flaks. Må kanskje ha begge deler for å komme så langt

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Når avtalen ble signert var det en total x-faktor når det gjaldt gjennomføringsevne på partneren. Så det er jo hyggelig å se hvor bra det har funket så langt, klockrent.

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Lost in translation.

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Yahong Pharma won the “Top Ten Innovative Drug Enterprises in 2024” by China Times
2024-11-25/Press release

Shanghai, China, November 25 – The 4th China Health Industry Development Conference and Golden Cane Award Ceremony, hosted by China Times and China Health Research Institute, was held in Beijing on November 22. The theme of this conference is “New Quality Productivity Leads Change· AI technology empowers innovation and development”, focusing on the development direction and cutting-edge trends of the big health industry under the support of scientific and technological innovation and policies.

With its excellent scientific research and innovative drug development capabilities, Yahong Pharma was awarded the honorary title of “Top Ten Innovative Enterprises in 2024”. The Golden Cane Award is an annual honorary award in the medical and health industry launched by China Times through the platform of the China Health Industry Development Conference, and enjoys a high reputation in the industry.

Innovative R&D is the core driving force of Yahong Pharmaceutical. Up to now, Yahong Pharma has 13 products and 18 projects under development. It is worth mentioning that since the beginning of this year, a number of core products of Yahong Pharmaceutical have made positive progress. The company’s APL-1706 was approved for marketing by the National Medical Products Administration; The marketing application for APL-1702 was accepted; APL-1202 and PD-1 inhibitor tislelizumab in combination with neoadjuvant treatment of muscle-invasive bladder cancer completed phase II clinical trial and achieved positive efficacy signals.

As a global specialty innovative drug company, Yahong Pharma focuses on genitourinary tumors and women’s health. Winning the “Top Ten Innovative Drug Enterprises in 2024” by China Times this time is a recognition of the company’s innovation strength. Adhering to the mission of “improving human health and making life more dignified”, Yahong Pharma will continue to devote itself to the clinical development and commercialization of specialized pipelines, further enhance the company’s innovation capabilities, promote the high-quality development of the pharmaceutical industry, and benefit more patients.

Yahong Pharmaceutical

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Og tenk at PHO’s utlisensierte produkter er de første som regnes som core products :grin:

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Plotta hele denne inn i GPT og ba den fortelle om resultatene og sannsynlighet for approval. Fikk dette:

Results from Phase III Clinical Trials of APL-1702 (“Little Red Riding Hood”)

The Phase III clinical trial for APL-1702, targeting high-grade squamous intraepithelial lesions (HSIL), has achieved its primary endpoint, a critical milestone for regulatory approval. Here’s a breakdown of the results:

  1. Pathological Regression Rates:
  • APL-1702 demonstrated a 15-20% higher pathological regression rate (CIN2 or CIN3 regressing to CIN1 or normal) compared to the placebo group.
  • This indicates significant efficacy in reducing HSIL severity.
  1. HPV Clearance Rates:
  • The treatment showed an improvement in overall HPV clearance rates, particularly for high-risk strains like HPV16 and HPV18.
  • HPV clearance is critical because persistent infection is the primary cause of cervical cancer.
  1. Age-Group Analysis:
  • Consistent efficacy was observed across different age groups (20-40 years), the primary demographic for cervical cancer prevention.
  • No cervical cancer events occurred during the trial, demonstrating safety and disease prevention potential.
  1. Safety Profile:
  • APL-1702’s non-invasive mechanism avoids the complications and risks associated with surgery (e.g., damage to cervical function, fertility issues).
  • The product uses a low-power LED light source with minimal discomfort or adverse effects.

Probability of Regulatory Approval

Based on the Phase III results and the drug development landscape, the probability of regulatory approval is high, but not guaranteed. Here are key considerations:

Strengths Supporting Approval:

  1. Achievement of Primary Endpoint:
  • Regulatory agencies like the FDA, EMA, and NMPA (China) prioritize meeting primary endpoints in pivotal trials.
  • APL-1702’s results demonstrate clear clinical benefits for a significant unmet need, fulfilling a core regulatory requirement.
  1. Safety and Efficacy:
    Non-invasive treatments with strong safety profiles are more likely to gain approval, especially when targeting high-risk conditions like HSIL.
  2. Unmet Need and Innovation:
    There are few non-invasive alternatives to surgery for HSIL, giving APL-1702 a differentiated position in the market.
  3. Regulatory Climate in China:
    China is actively promoting innovative healthcare solutions, making the NMPA’s approval pathway favorable for such treatments.

Potential Risks:

  1. Data Robustness:
    Subgroup analysis showed limited data for patients under 20 and over 40, which could prompt regulators to request additional studies for these populations.
  2. Manufacturing and Scalability:
    Commercial production of such a novel product (combining HAL photosensitizers and portable devices) may require additional regulatory scrutiny.
  3. Global Approvals:
    If Asieris Pharmaceuticals seeks FDA or EMA approval, additional trial data might be required to meet diverse regulatory standards.

Probability Estimate:

  • China (NMPA): 80-90%, given the product’s innovation, local trial success, and supportive policy environment.
  • Global (FDA/EMA): 60-70%, contingent on additional trials and localized regulatory alignment.

Next Steps to Watch:

  • Submission of the New Drug Application (NDA) to regulators.
  • Confirmation of manufacturing readiness and commercial scalability.
  • Updates on post-trial monitoring or additional supportive studies.

For investors, the achievement of the primary endpoint is a strong signal that APL-1702 is on track for approval and market launch, making this a promising near-term opportunity.

(Edits: korrigert formateringer)

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Briarwood på kjøperen frem mot nyttår, ja takk.

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Kan du prøve en gang til på Chatgpt og opplyse at søknad om nda er innsendt og søknaden som søknad er akseptert for lengst. Evt spørsmålsrunder har dermed antatt funnet sted. Asieris er dermed ett godt skritt lenger. Dermed bør sannsynlighetene for godkjennelse være høyere enn chartgpt har beregnet og sannsynlighet for mulige tilleggsrunder er redusert.
Produksjonsfasiliteter og skalerbarhet skulle vel også være på plass allerede.

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Fin dag i går.
Får håpe den fortsetter i dag hvis ikke de som styrer robotene er kvitt feberen og kommet seg på jobb igjen i dag.

Tilbake på jobb ja

Selvfølgelig er robotene på jobb :cry: Og det var de i går også, det syns bare ikke så tydelig når det er mange kjøpere og selgere på banen. Men man ser det hver gang man forandrer limit på en ordre, i det øyeblikk man bekrefter endringen forandrer seg antall på alle nivåer med lysets hastighet :wink:

Alle aksjene jeg eier burde være verdt mer, men det er hele tiden selgere der som presser kursen. Er det da robotenes skyld i alle aksjer ?

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Fundamentalt sett er det kun mangel på kjøpere på topp 20 og topp 50 som kan holde en aksje nede. Nå så vi jo nettopp at største eier plukket opp 214.000 aksjer. Er ikke så vanvittig mange sånne kjøp som skal til for at det blir et kjøpssug i aksjen.

Så lenge det ikke akkumuleres på topp 50 er det veldig enkelt for store pengesekker å flytte aksjen ned og opp innenfor denne tradingrangen, det blir selvforsterkende fordi det er en del som har oppdaget at det er en inntekt å hente på å trade PHO.

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De 20 største aksjonærene har nå kommet opp i 56,64% de høyeste jeg har notert.
Ser og på aksjelisten i dag at det var mange som solgte seg ut.

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De 20 største aksjonærer eier nå 56,64% av selskapet. Har det noen gang før vært høyere eierandel her?

https://www.photocure.com/investors-hub/investors-shareholder-information

Var 56,83% 19.01.2024

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Solid, good! Veldig stabilt over lang tid. Vet ikke hvordan det skal tolkes, men det er da ikke lett å plukke solide poster uten å bevege kursen betydelig antar jeg?

Briarwood plukket 214.000 mens kursen sank flere kroner, så det er jo åpenbart mulig. :stuck_out_tongue:

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:laughing:utrolig nok. Kan synes som et rart «stunt»?