Done! Har mer aksjer enn jeg noensinne har hatt i photocure
De 270?
Hehe, nei jeg har nok lastet tidligere. Har for mye ocd til Ă„ kjĂžpe et slikt antall
Pho en av ABG sine noksÄ fÄ doblingskandidater (hÞyest potensiell avkastning) pÄ OSE, og da skal vel kanskje kursen ytterligere ned i mellomtiden⊠eller ?
Har ABG dekning pÄ PHO?
SHANGHAI, Aug. 28, 2024 /PRNewswire/ â Asieris Pharmaceuticals today released its 2024 Semi-Annual Report, showcasing a strong growth momentum. The launch of its blockbuster product APL-1702 is progressing smoothly, while the Commercial Team continues to enhance revenue-generating capabilities. The companyâs pipeline is advancing and broadening, currently with 13 major products and 18 ongoing research projects. As of the end of this reporting period, Asieris had approximately RMB 2.024 billion in cash, cash equivalents, and financial assets held for trading, ensuring ample capital for the companyâs continued growth and expansion.
Advancing Launch of APL-1702 to Meet Strong Demand for Non-Invasive Treatment of Precancerous Cervical Lesions
The new drug application for APL-1702, a combination of drug and medical device designed for photodynamic non-surgical treatment of cervical high-grade squamous intraepithelial lesions (HSIL), was accepted by the National Medical Products Administration (NMPA) in May 2024. The review process is progressing smoothly.
APL-1702 is a groundbreaking product that combines innovative, clinical, and social value. As a first-in-class treatment to be debuted in China, backed by proven efficacy in an international phase III trial, it is poised to become the worldâs first non-invasive therapy for HSIL. Clinically, APL-1702 is set to redefine the treatment paradigm of precancerous cervical lesions, moving beyond the one-size-fits-all approach of cervical resection. It aims to reverse disease progression while preserving the cervix, avoiding damage from resection, and supporting long-term management and recurrence prevention. From a societal perspective, managing HSIL patient is a crucial step in the âearly diagnosis and early treatmentâ of cervical cancer. APL-1702 combines the value of early cervical cancer intervention and the promotion of a fertility-friendly society, and it is expected to contribute to the success of the Action Plan for Accelerating the Elimination of Cervical Cancer (2023-2030) and the Healthy China Initiative.
To support the commercialization of APL-1702, the company formally established the Womenâs Health Business Unit in early 2024. This unit is responsible for the domestic commercialization of APL-1702 in the Chinese market and expanding the companyâs gynecological pipeline. Key members, including the BU head and teams for marketing, government affairs, and regional commercialization, have already come on board, all bringing extensive experience in gynecology and multinational pharmaceutical companies. In the first half of this year, the Womenâs Health Business Unit conducted thorough market and industry research, developed a key launch plan for APL-1702, and actively prepared the commercial supply chain to ensure the productâs rapid market availability following its approval.
The company has also convened three expert consultation meetings focusing on key topics such as review and dissimilation of phase III clinical data of APL-1702, the current state of HSIL diagnosis and treatment, and clinical needs. The meetings garnered strong endorsements from the principal investigators and leading national gynecologists, highlighting the innovation and clinical value of APL-1702. With this expert backing, the Womenâs Health Business Unit is pursuing strategic partnerships with government departments and industry associations to advance cervical cancer control and help shape a long-term management framework for precancerous lesions. Preparations are well underway, and a cooperation agreement is expected to be signed and implemented in the second half of the year.
Given the scarcity of innovative drugs in gynecology, APL-1702 stands out with its solid clinical evidence and proven efficacy. Moving forward, the company will leverage APL-1702 and its drug-device combination platform to build a robust gynecological portfolio through external partnerships, indication expansion, and proprietary second-generation products.
Commercial Capabilities Continue to Strengthen: Operating Revenue Increased by 130.98% from Q1 to Q2
Alongside strong commercialization performance, the Oncology Business Unit is actively preparing for the launch of new products. The new drug application for APL-1706, a diagnostic and management agent for bladder cancer, was accepted in November 2023. Currently, APL-1706 is the worldâs only imaging agent approved to assist bladder cancer diagnosis or surgery. It has passed inspection by the Center for Food and Drug Inspection (CFDI), with NMPA approval expected by the end of June 2025.
The Oncology Business Unit is refining a launch plan for APL-1706, exploring opportunities beyond surgical applications, such as outpatient examinations and strategic partnerships. The aim is to broaden market reach and benefit more patients. The team is developing strategies for post-launch access, pricing, expert endorsement, clinical collaboration, and dealer networks.
Additionally, the company will build on its strong brand positioning with a strategy that combines in-house research and in-licensing, will actively pursue external partnerships to further enhance its commercial competitiveness and strengthen its position in oncology.
Commit to Innovation and Drive Pipeline Expansion and Development Worldwide
Guided by its strategy, Asieris has made significant strides in multiple clinical development programs in the first half of the year, with a strong push for global presence.
In the field of womenâs health, following the positive results of the international phase III trial for APL-1702 and recognizing the substantial unmet clinical needs, Asieris plans to submit a pre-submission to the European Medicines Agency (EMA) in the fourth quarter of 2024. It also aims to be in discussion with the US Food and Drug Administration (FDA) this year on the design of a pivotal clinical program for the North American market and will apply for a phase III trial in due course. The company has also begun development of the HPV clearance indication.
Dr. Kevin Pan, Founder, Chairman and CEO of Asieris Pharmaceuticals, commented, âWe remain optimistic and confident about the future of Asieris. The launch of our two core products, APL-1702 and APL-1706, is on track and set to address critical unmet medical needs in their respective fields. This progress underscores our commitment to clinical value generation and ensures that patients will soon have access to our innovative products. We also saw strong growth in commercialization, reduced operational costs, and increased efficiency in the first half, showcasing our ability to meet strategic goals. Looking ahead, we will remain focused on genitourinary tumors and womenâs health, aiming to deliver even greater value to both society and our shareholders.â
Ser fint ut det
Artig at dem definerer bÄde 1702 og 1706 som kjerneprodukter i deres portefÞlje.
âdeveloped a key launch plan for APL-1702, and actively prepared the commercial supply chain to ensure the productâs rapid market availability following its approval.â
Takk for deling. Asieris virker veldig solid og pÄlitelig ut fra hva de skriver.
Liker spesielt frasen âis on trackâ. Her blir de business til slutt.
âThe launch of our two core products, APL-1702 and APL-1706, IS ON TRACK" and set to address critical unmet medical needs in their respective fields. This progress underscores our commitment to clinical value generation and ensures that patients will soon have access to our innovative products.â
De satser heftig pÄ Cevira, dette blir spennende!
Tror ikke man ikke utelukke en positiv overraskelse over hvor raskt det kommer en godkjenning? Vanskelig Ä tolke utover at de lobber pÄ det de kan.
De refererer ogsÄ til Nà R det blir godkjent, og ikke OM.
SĂ„ godkjennelse innenfor 19 mnd. for Hexvix. Stemmer godt med forventning og da er Cevira godkjent innen des. 2025.
Blir ikke overrasket om det blir desember 2024 slik som Cevira omtales.
Europa kan ogsÄ vÊre pÄ gang da
BÞr se kraftig kursoppgang pÄ Photocure i morgen. Knallsterk rapportering fra Asieris.
Det var ikke mye tegn til forventninger om det idag, Kan den karre seg over 50 igjen imorgen?
Er vel ikke sÄ mange som fikk det med seg fÞr bÞrsslutt.
Hvis PHO ikke blir solgt fÞr Ceviragodkjennelsen, sÄ vil Algetaoppturen bli barnemat iforhold til det PHO aksjonÊrene vil oppleve. Algeta var vel ogsÄ nesten pÄ all time low fÞr oppturen begynte.
blockbuster product APL-1702
In the first half of this year, the Womenâs Health Business Unit conducted thorough market and industry research, developed a key launch plan for APL-1702, and actively prepared the commercial supply chain to ensure the productâs rapid market availability following its approval.
The company has also convened three expert consultation meetings focusing on key topics such as review and dissimilation of phase III clinical data of APL-1702, the current state of HSIL diagnosis and treatment, and clinical needs. The meetings garnered strong endorsements from the principal investigators and leading national gynecologists, highlighting the innovation and clinical value of APL-1702. With this expert backing, the Womenâs Health Business Unit is pursuing strategic partnerships with government departments and industry associations to advance cervical cancer control and help shape a long-term management framework for precancerous lesions. Preparations are well underway, and a cooperation agreement is expected to be signed and implemented in the second half of the year.
Given the scarcity of innovative drugs in gynecology, APL-1702 stands out with its solid clinical evidence and proven efficacy. Moving forward, the Company will leverage APL-1702 and its drug-device combination platform to build a robust gynecological portfolio through external partnerships, indication expansion, and proprietary second-generation products.
The launch of our two core products, APL-1702 and APL-1706, is on track and set to address critical unmet medical needs in their respective fields. This progress underscores our commitment to clinical value generation and ensures that patients will soon have access to our innovative products.