Ja en skulle tro det er en forbannelse over aksjen.
Ja måske det er tid til at kontakte en præst, så vi kan få forbandelsen hævet.
I likhet med mange andre biotekaksjer er kursen i Pho nyhetsdrevet. Etter at nyheter er sluppet, gjerne i forbindelse med en kvartalspresentasjon, kommer det gjerne en nyhetstørke, der kursen mister momentum.
Med litt påpasselighet kan man tjene på de kursvariasjonene som da kommer.
Riktignok ga presentasjonen nå gode tegn til fremganger, men det er et stykke frem i tid, bortsett fra at 3q nok blir en god del bedre enn 2q. Det kan også komme nye milepæler i 3q ved søknadsinnsendelser.
Men hovedgrunnen til å sitte stille i båten fremover er Cevira.
1 Like
Enkelt resyme fra Simply Wall Street:
Second quarter 2024 earnings: Revenues exceed analysts expectations while EPS lags behind
Second quarter 2024 results:
- EPS: kr0.45 (up from kr0.16 in 2Q 2023).
- Revenue: kr145.4m (flat on 2Q 2023).
- Net income: kr12.3m (up 186% from 2Q 2023).
- Profit margin: 8.5% (up from 3.0% in 2Q 2023).
Revenue exceeded analyst estimates by 10%. Earnings per share (EPS) missed analyst estimates by 10.0%.
Revenue is forecast to grow 16% p.a. on average during the next 3 years, compared to a 7.7% growth forecast for the Pharmaceuticals industry in Europe.
Over the last 3 years on average, earnings per share has increased by 19% per year but the company’s share price has fallen by 25% per year, which means it is significantly lagging earnings.
2 Likes
News flow og kursutvikling korresponderer ikke i denne aksjen, det ligger til rette for en saftig rekyl.
2 Likes
The first batch of pilot projects of the new regulations on the review and approval of innovative drug clinical trials have been announced, and related companies are expected to benefit
The development of innovative drugs is expected to speed up again. On August 2, the National Medical Products Administration announced that it agreed to carry out a pilot program to optimize the review and approval of innovative drug clinical trials in Beijing and Shanghai. This is also the first batch of pilot areas to pass the review since the issuance of the pilot work plan for optimizing the review and approval of innovative drug clinical trials.
The “Pilot Work Plan for Optimizing the Review and Approval of Innovative Drug Clinical Trials” reviewed and approved by the National Medical Products Administration on July 30 proposed that it is planned to explore the establishment of a work system and mechanism to improve the quality and efficiency of drug clinical trials for the key links of the speed limit of innovative drug clinical trials, and to complete the review and approval of innovative drug clinical trial applications (IND) within 30 working days.
This also means that Beijing and Shanghai are expected to be the first to compress IND review and approval to within 30 working days. "Before conducting clinical research on new drugs, pharmaceutical companies need to provide data to the drug regulatory authorities to prove that the drugs are safe and reasonable for conducting clinical trials. Only after approval can clinical trials be carried out.
IND is a crucial link in the life cycle of new drug research and development. In the past, relevant review and approval generally took 60 working days. If it can be compressed to 30 working days, the clinical advancement of innovative drugs will undoubtedly be greatly accelerated." An industry analyst told the Securities Daily reporter.
« Recently, a series of support policies for the innovative drug industry have been introduced, and we have seen the government’s determination to encourage the development of innovative drugs. These policies provide strong support for innovative pharmaceutical companies,» said Yahong Pharmaceuticals
Yahong Pharmaceuticals also stated that the company’s new drug application for APL-1702, the world’s first non-surgical treatment for high-grade cervical squamous intraepithelial lesions, has been accepted, and is currently actively promoting its review, approval and listing. APL-1702 is expected to become the world’s first and China’s first non-invasive innovative treatment for cervical precancerous lesions.
It is hoped that with the implementation of relevant policies, it will help companies bring innovative drugs to the market earlier and provide patients with more treatment options
Recently, Shanghai issued the “Several Opinions”, which introduced 37 policy measures in eight aspects, including vigorously enhancing innovation source capabilities, promoting clinical resources to better empower industrial development, further accelerating review and approval, accelerating the application and promotion of innovative products, strengthening services for enterprises and support for industrialization, strengthening investment and financing support, releasing the value of data element resources, and promoting the internationalization of the industry.
“From the ‘Several Opinions’ recently released by Shanghai, we see the government’s determination to encourage the development of innovative drugs. Recently, a series of support policies for the innovative drug industry have been released, providing strong support for innovative pharmaceutical companies. This is undoubtedly a good thing for companies.” A relevant person in charge of Yahong Pharmaceuticals said in an interview with reporters.
“We hope that with the implementation of relevant policies, we can help companies bring innovative drugs to the market earlier and provide more treatment options for patients.”
The above-mentioned person in charge said that as far as Asieris Pharmaceuticals itself is concerned, the company will adhere to the specialization strategy, concentrate the company’s resources, and make in-depth layouts in the fields of urogenital tumors and women’s health.
At present, the company’s new drug application for APL-1702, the world’s first non-surgical treatment of high-grade cervical squamous intraepithelial lesions (HSIL), has been accepted, and the company is actively promoting its review, approval and listing
10 Likes
Creating differentiated innovative products and focusing on unmet clinical needs as a foundation for future commercialization has always been the core focus of innovation and R&D.
Five years ago, the STAR Market (Science and Technology Innovation Board) introduced the fifth set of listing standards, paving the way for the listing of innovative pharmaceutical and medical device companies. Five years later, 20 companies have gone public on the STAR Market under the fifth set of standards, with Asieris Pharmaceuticals being one of them. By leveraging the capital market, Asieris continues to innovate and grow.
The company’s core product, APL-1702, is expected to become the world’s first and China’s first non-invasive photodynamic therapy for cervical precancerous lesions, filling a treatment gap in China.
“From the perspective of an innovative pharmaceutical company, we hope to further broaden refinancing channels under the premise of addressing unmet clinical needs and improving treatment paradigms,” said Asieris Pharmaceuticals. “The funding required for innovative drug R&D is often significant, and the need for timely financing is urgent. With more support from the capital market, the explosive power of pharmaceutical innovation in the future will be unlimited.”
Significant progress in several innovative products
Over the past two years, the company has successfully advanced the development of several innovative products, addressing unmet clinical needs and offering more options to patients in scenarios with limited treatment options.
In May 2024, a core product of Asieris Pharmaceuticals achieved significant R&D progress: the new drug application for APL-1702, a non-surgical treatment for high-grade squamous intraepithelial lesions (HSIL), was accepted.
“The company is actively promoting the review and approval process for its market launch,”
Asieris Pharmaceuticals explained. APL-1702 features innovations in formulation improvement, clinical development, registration procedures, and treatment pathways, primarily in the following three areas:
-
Global First, China First: APL-1702 is expected to become the world’s first non-invasive therapy for HSIL supported by high-level clinical evidence, and the first to be launched in China. It could be the first globally validated HSIL non-invasive therapy proven effective through international phase III clinical trials.
-
Drug-Device Combination: APL-1702 addresses issues that cannot be solved by drugs or devices alone, representing a pioneering approach. This innovation sets a practical example for the evaluation and management processes of drug-device combinations.
-
Redefining Treatment Goals for Cervical Precancerous Lesions: Traditionally, HSIL treatment often involves cervical excision, but APL-1702 aims to reverse the disease progression while preserving the cervix, thereby avoiding the damage associated with delayed excision. This approach supports long-term disease management and better addresses recurrence.
Previously, in November 2023, the new drug application for Asieris Pharmaceuticals’ bladder cancer diagnostic and management drug APL-1706 was also accepted. This product is currently the world’s only approved contrast agent for assisting in bladder cancer diagnosis or surgery.
"We hope to obtain market approval in the first half of 2025," Asieris Pharmaceuticals stated.
"Asieris Pharmaceuticals is very optimistic about the market potential of these products, particularly APL-1702.
Each year, 600,000 to 700,000 women are diagnosed with high-grade cervical lesions, and 90% of these patients undergo cervical excision. The launch of APL-1702 could help hundreds of thousands of women annually avoid cervical excision, eliminate lesions or clear HPV infection, reverse disease progression, preserve fertility, and address unmet clinical needs. We believe that the product’s market launch will not only benefit more patients but also contribute significantly to the company’s performance," Asieris Pharmaceuticals noted.
Multiple Measures to Promote Commercialization
“Being fully prepared for success or failure and having a meticulous development strategy are crucial,” Asieris Pharmaceuticals emphasized. Unlike biotech companies that broadly research multiple indications around popular targets, Asieris has focused its resources from the outset on a specialized strategy, targeting two niche areas: bladder cancer and cervical precancerous lesions. This focused strategy has gradually yielded significant results.
Beyond its focused R&D efforts, Asieris Pharmaceuticals has also developed a clear strategy for operations and commercialization. The company emphasizes cost control and efficiency in operations, ensuring that resources are allocated effectively to key projects. In terms of commercialization, Asieris has quickly built a capable marketing team through product acquisitions and is fully committed to the successful market launch of APL-1702 in China to achieve commercial success as soon as possible.
Furthermore, Asieris Pharmaceuticals is actively pursuing overseas development and partnership opportunities for APL-1702 and APL-1202/APL-1501, aiming to reduce overseas development costs through out-licensing and increase the company’s cash flow.
12 Likes
Dette gjør jo PHO til en no-brainer
4 Likes
Hvor kommer disse 18 mnd det har vært snakk tidligere inn her?
Er resten av tiden venting til å bli plukket ut a bunken for behandling?
Eller er det slik at disse 60 WORKING DAYS er dager spredt ut over etterhvert som den blir behandlet og løftet igjennom systemet i forkjellige instanser?
Liker dette spesielt godt. 
1 Like
Trenger ikke å tvile på hva Asieris satser på. 
1 Like
Ser ut til at Kina dermed etablerer raskere prosedyrer med beslutning så sent som i juli i år. Kanskje det er selve implementeringen av nye administrative prosedyrer som gjør at vi har måttet vente på Ceviramarkedsgodkjennelsen?
I så fall er markedets bekymring over tidsbruken her misforstått!
Ikke bland IND med NDA.
Asieris selv bekrefter jo 12-18 mnd.
For Hexvix (APL-1706) sier de selv:
" We hope to obtain market approval in the first half of 2025," Asieris Pharmaceuticals stated.
Altså ingen grunn til å forvente noe annet for Cevira.
5 Likes
Q4: How long does it take for a drug to be approved in China?
A4: The average time taken for a drug to get approved in China is approximately one (01) to two (02) years. However, the actual time may vary, depending on the complexity of the specific drug and the availability of clinical data.
og:
Når det gjelder forventet godkjenning for produktene til Asieris er det kun APL-1706 som nevnes - 1H 2025 - som dermed er innenfor gjennomsnittstiden 18 mnd.
Med det sagt er key takeaway for meg at Asieris ikke gir noen estimert tidslinje for Cevira i tråd med ovennevnte, og at de aktivt følger opp review-prosessen. Dette kan være tett dialog med NMPA for å sikre at all nødvendig dokumentasjon og informasjon er levert, avklare aktuelle spørsmål og sørge for en mest mulig smidig prosess.
“ The company is actively promoting the review and approval process for its market launch ,”
Artiklene er også ladet med relevante stikkord ift. kvalifisering til hurtigere godkjenningsløp. At de håper på og/eller er optimistiske rundt dette er det jeg leser. Ren spekulasjon selvfølgelig.
I dette spesifikke tilfellet leser jeg dette som review i forkant av en eventuell clinical trial
5 Likes
Gledelig indikasjoner!
Gledelig for pasienter med data som er vist.
Skulle ikke forundre meg om de fleste skribenter ikke er inne. Fair det. Kanskje lurt også? Hvem vet.
Så det nå, kjørte artikkelen igjennom en AI for en kjapp oppsummering, så 60 til 30 dagar har ingen påvirkning for selve APL-1702 eller Hexvix, da begge disse er langt forbi disse stadiene.
Men takk for oppklaring.
3 Likes
Juli 2025 er jo plutselig ikke så veldig lenge til. Rart det her med tiden.
Spesielt for selskaper som har årevis med penger på bok
5 Likes
Innen dette segment er det vel langt fra unaturlig med solid prising av forventinger produkt i marked / markedstilgang om under 12 mnd og her er partner etablert som dekker kostnader og gir royalties og milestones som er signert avtale. Her prises nada kan det se ut til? Ganske unikt?
Ser også at de største 20 eierne fortsatt og over tid har sin totale 56% eierandel
Basert på svært depressiv stemning på ulike tråder ser det ikke ut som det er mange småaksjonærer igjen i selskapet.
Mulig biased, men synes det var riktig så god presentasjon og informasjon med en rekke gode initiativ og prestasjoner oppnådd. Langt fra en pølsebod som enkelte gjentar svært ofte.
Se transcript:
https://tekinvestor.no/uploads/short-url/zEw8c8fS1AQSBpsMJdO7s2aMKix.pdf
https://www.photocure.com/investors-hub/investors-shareholder-information
3 Likes
Trends and Characteristics of New Drug Approvals in China, 2011–2021
In the past decade, the Chinese drug regulatory system has undergone many changes. A major reform starting in 2015 has significantly reshaped the regulatory processes. It was important to assess the impact of the reform on new drug approvals in China
A total of 353 new drugs were approved, including 220 small molecule drugs, 86 biological products and 47 vaccines. The annual number of new drug approvals increased dramatically since 2017, reaching a record high of 70 in 2021. The median NDA approval time was 15.4 months in 2017-2021, the shortest in the decade, and was significantly shorter than that in the pre-reform period. The newly instituted expedited pathways such as priority review (PR) and accelerated approval for urgently needed overseas drugs (UNOD) significantly reduced new drug application (NDA) approval times compared with standard review.
A recent report focusing on the innovative drug development in China also showed a significant reduction in NDA approval for innovative drugs in the post-reform period
The updated Drug Registration Regulation stipulates a statutory NDA review and approval time limit of 225 working days (approximately 10.3 months) for standard review and 155 working days (approximately 7.1 months) for priority review, which are getting closer to the US FDA’s benchmark. We anticipate that the NDA approval time in China will further decrease as more applications are now covered under this approval time limit mandate.
Hvis en ser til "Innovative Drug Development " kan man se mot godkjenning innen Mars 2025. Hvis den i tillegg kvalifiserer til Priority Review under samme kategori (noe som i så fall burde vært kommunisert) vil godkjenning finne sted mot slutten av 2024.
Altså er 1H 2025 særdeles spennende for Asieris og Photocure med potensiell launch av både APL-1702 og APL-1706.
10 Likes
Da har jeg lest gjennom dagens ørten innlegg og kan vel konkludere med at intet har forandret seg. Bare å forberede seg på lang til veldig lang venting, som vanlig 