Kina vil ytterligere akselerere gjennomgangen og godkjenningen av innovative legemidler og medisinsk utstyr som er presserende nødvendig i klinisk praksis
Tid: 2024-09-13 Kilde: Xinhua News Agency
Li Li, direktør for State Food and Drug Administration, sa 13. september at han ville fremskynde gjennomgangen og godkjenningen av innovative legemidler og medisinsk utstyr som er presserende nødvendig i klinisk praksis, inkludere kvalifiserte produkter i den prioriterte gjennomgangs- og godkjenningsprosessen, forkorte fristen for teknisk gjennomgang, registreringsverifisering, registreringsinspeksjon og andre lenker, og øke hastigheten på godkjenningen.
Dette ble introdusert av Li Li på en rekke pressekonferanser om temaet “Fremme utvikling av høy kvalitet” som ble holdt av informasjonskontoret til statsrådet samme dag. Fra januar til august i år godkjente State Food and Drug Administration 31 innovative legemidler og 46 innovative medisinske enheter, en økning på henholdsvis 19 % og 12 % i forhold til samme periode i fjor.
Li Li sa at State Food and Drug Administration vil fortsette å øke sin støtte til farmasøytisk FoU og innovasjon, styrke tjenesteveiledningen i gjennomgang og godkjenning, inspeksjon og verifisering av innovative legemidler og medisinsk utstyr støttet av staten, og veilede bedrifter til å følge kliniske verdiorienterte og pasientsentrerte FoU-strategier; Styrke den politiske publisiteten og den tekniske konsultasjonen av produktregistrering og deklarasjon, integrere den tekniske styrken til nasjonale og provinsielle legemiddelreguleringsavdelinger, etablere kommunikasjonsmetoder på flere kanaler og flere nivåer, og bruke nettkanaler for å drive et skyklasserom for gjennomgang og godkjenning av legemidler og medisinsk utstyr; Forbedre tilgjengeligheten til innovative legemidler og medisinsk utstyr, implementere beslutningstaking og distribusjon av partiets sentralkomité for å utdype den koordinerte utviklingen og styringen av de “tre medisinene”, og aktivt støtte innovative legemidler og enheter for å komme inn på sykehus og medisinsk forsikring.
Samtidig vil effektiviteten av gjennomgang og godkjenning forbedres, fristen for underforstått godkjenning av kliniske studier vil bli forkortet, og pilotprosjekter vil bli gjennomført i Beijing, Shanghai og andre steder, for å redusere fristen for gjennomgang og godkjenning av kliniske studier av innovative legemidler fra 60 virkedager til 30 virkedager. Optimaliser gjennomgangs- og godkjenningsprosedyrene for supplerende legemiddelsøknader, gjennomfør pilotprosjekter i kvalifiserte provinser, gi verifisering av endringsregistrering etter markedsføring og inspeksjonstjenester for legemidler, og reduser fristen for gjennomgang av supplerende søknader betraktelig.
I tillegg vil det også støtte åpningen og samarbeidet med farmasøytisk industri, styrke transformasjonen og implementeringen av internasjonale generelle regulatoriske regler i Kina, støtte utviklingen av internasjonale multi-senter kliniske studier, og fremme synkron forskning og utvikling, samtidig anvendelse, samtidig gjennomgang og samtidig notering av globale legemidler i Kina; Utforske den segmenterte produksjonsmodellen for biologiske produkter, og gjennomføre pilotprosjekter for segmentert produksjon av innovative og klinisk presserende biologiske produkter i noen regioner; Vi vil øke støtten til import- og eksporthandel med legemidler, fremskynde godkjenningen av nye legemidler som er markedsført utenlands i Kina, og oppmuntre multinasjonale selskaper til å overføre originale kjemiske legemidler, biologiske produkter og avansert medisinsk utstyr til innenlandsk produksjon. Forbedre de relevante retningslinjene for salgssertifikater for legemiddeleksport, og oppmuntre flere farmasøytiske selskaper i Kina til å gå utenlands.
2 Likes
Cevira (APL-1702): Photocure Partner Asieris Unveils Efficacy Data of Non-Surgical Treatment of Cervical HSIL at the 2024 PDT&PD Conference
24 Likes
This study is a prospective, randomized, double blind, placebo controlled, multicenter phase Ⅲ clinical study, which has reached its primary efficacy endpoint and exhibited good safety.
Furthermore, the study results indicated that the pathological regression rate (defined as the proportion of subjects with a pathological regression to CIN1 or normal tissue) at the 6th month in different age subgroups, both the “≥20 and <30 years” subgroup and the “≥30 and <40 years” subgroup showed an increase of 15% to 20% in the pathological regression rate in the APL-1702 group compared to the placebo (PBO) control group. No cervical cancer events were reported, suggesting a significant therapeutic potential of APL-1702 in the HSIL population aged 20 to 40 years.
4 Likes
Photocure Partner Asieris Unveils Cevira (APL-1702) Phase III Subgroup Analysis by Age Groups at the 2024 CSCO Annual Meeting
21 Likes
-
CMO [Chief Medical Officer]
(Remote, US)
Asieris Pharmaceuticals (688176.SH), founded in March 2010, is a global innovative biopharma company specializing in the genitourinary tumors and other diseases with highly unmet medical needs. We strive to improve human health and help patients live in a more dignified life. We aim to become a global leader that integrates R&D, manufacturing and commercialization in our areas of focus, by providing integrated solutions from diagnosis to treatment to patients in China and worldwide.
We are seeking a highly motivated and experienced leader as the company’s Chief Medical Officer as a core team member for the global development of APL-1702 (Cevira®).
Principal Duties and Responsibilities
- Lead the regulatory interactions with the FDA, and achieve the goal of obtaining FDA’s consensus of APL-1702’s US phase III trial design with manageable risks;
- Lead the regulatory interactions with the EMA, and achieve the goal of understanding EMA’s expectations for approval, and more ideally the goal that these expectations can be satisfied by APRICITY data;
- Build a strong network with KOLs in the US and EU and address inquiries from regulatory agencies, and potential partners and investors.
- Provide expert opinions to Asieris teams for the strategies and plans to build a strong pipeline in Women’s Health in China. More specifically, help the product team of APL-1702 to build the clinical development plan for new indications such as anti-HPV infections, for the China and worldwide markets.
- As a key member of the fund-raising activities to support global development of APL-1702 (Cevira®), develop and optimize a compelling business plan, with a focus on product competitive advantages, clinical development plan and cost estimates;
- Answer questions from investors and ensure clear understanding of key elements of the business plan, such as clinical and regulatory roadmaps, risk and risk management plans, values of the product, and etc.;
- Help the enrichment of clinical pipeline by providing critical evaluation of potential in-licensing opportunities;
- Help the recruiting of core management team by recommending candidates and providing critical evaluations during interviews.
Job Requirements
- MD, MD-PhD, or significant related experience supporting comparable contributions, with substantial industry drug development experience and record of accomplishment
- Experience or exposure to pivotal-stage development is required. Therapeutic area experience in oncology/Women’s Health is required
- Experience with non-traditional development is highly valued, e.g. novel biology, niche/rare disease clinical indications, new therapeutic modalities, alternative endpoints, and/or regulatory pathways (including familiarity with rapid development approaches such as Fastrack, Breakthrough and PRIME designations as well as differences between FDA and EMA mechanisms)
- Ability to lead and execute in a nimble, entrepreneurial, cross-functional, and highly collaborative culture is essential
- Strong leadership, interpersonal and communication skills
- Effective executive leadership and influence that will engender collaboration and open communication, champion for innovation, and stimulate out-of-the-box thinking and change.
Head of BD
(Shanghai/China.)
Business Development
a) Formulate business development strategy to be aligned with corporate growth strategy.
b) Build an extensive network in pharma and biotech communities to search, identify and evaluate potential partnership opportunities.
c) Interface with internal R&D and commercial functions to effectively meet their business needs and help strengthen corporate branding.
d) Structure, negotiate and finalize deal transactions: Which will include out-licensing and in-licensing drug assets, strategic partnership, and other larger deals such as M&A and joint-ventures if candidate has adequate capabilities and experiences.
Team Management
e) Lead & motivate a highly professional BD team to execute the strategy and plans accordingly.
f) Develop the team capabilities and prepare for the organization of its BD talent pipelines.
1 Like
Denne holdningen som Asieris har angående Cevira levner ingen tvil om at produktet kommer på markedet.
3 Likes
Dette innlegget ble rapportert og er midlertidig skjult.
1 Like
Photocure Partner Asieris announces Marketing Approval by the National Medical Products Administration for Hexvix in China
31 Likes
Asieris Showcases World’s 1st Product for Non-Invasive Treatment of Precancerous Cervical Lesions at its CIIE Debut
(November 5, 2024, Shanghai) Asieris Meditech (Hong Kong) Co., Limited, a global biotech company specializing in life sciences, made its debut at the 7th China International Import Expo (CIIE). In collaboration with key partners, the company is showcasing a pioneering prevention and control system aimed at accelerating the elimination of cervical cancer in the CIIE innovation incubation zone. Asieris also debuted several cutting-edge products and technologies at the CIIE, including the world’s first non-invasive treatment for precancerous cervical lesions, a revolutionary alternative to traditional surgery that preserves cervical integrity. This innovative product safeguards women’s fertility while enhancing efforts to eliminate cervical cancer, contributing to China’s commitment to fertility-friendly prevention strategies for cervical cancer.
Comprehensive Cervical Cancer Prevention and Control Exhibition at CIIE
The innovative system for accelerating cervical cancer elimination is a holistic, three-tiered approach, combining vaccination, screening, early diagnosis and treatment to protect women’s reproductive health and curb the onset of cervical cancer. At this year’s CIIE, Asieris Hong Kong, in collaboration with more than 10 partners, such as Roche Diagnostics Cervical Cancer Innovation Platform, Hologic Women’s Health Diagnostics Innovation Center, and QIAGEN Smart Innovation Park, presented a comprehensive cervical cancer prevention and control system in a real-life exhibit, with support and guidance from the Cancer Foundation of China.
Cervical cancer is a highly preventable disease with a well-established cause. In 2020, the World Health Organization (WHO) launched its Global Strategy to Accelerate the Elimination of Cervical Cancer, through adoption of a resolution by 194 countries, including China. To advance the Healthy China 2030 initiative, and support the WHO’s Cervical Cancer Elimination Initiative, the Chinese government has issued key policies, including the Healthy China Initiative: Implementation Plan for Cancer Prevention and Control and the Action Plan for Accelerating Elimination of Cervical Cancer (2023-2030). At a recent press briefing on “Accelerating Elimination of Cervical Cancer,” the National Health Commission revealed that the risk of cervical cancer is rising in China, particularly among younger women, signaling that there is still much to be done in the fight to control and prevent this disease.
Global and China Debut of Cutting-Edge Products to Advance Cervical Cancer Prevention and Control
The prevention and control system integrates new products, technologies, and services from around the globe, spotlighting essential components and processes in the comprehensive cervical cancer prevention and control chain. At this year’s CIIE, a selection of pioneering products and technologies made their global and China debut, showcasing cutting-edge advancements that represent new quality productive forces. Key highlights include the world’s first photodynamic drug-device combination for the non-invasive treatment of precancerous cervical lesions, with efficacy proven in a global phase III trial; the first HPV test product to receive WHO prequalification (PQ) certification for cervical cancer screening; the first and only FDA-approved digital diagnostic system with an AI algorithm for cervical diagnosis; and the cobas HPV test kit, the first FDA-approved primary screening tool for cervical cancer.
Among the standout innovations at this year’s CIIE is APL-1702, an advanced product from Asieris Hong Kong designed for the non-invasive treatment of precancerous cervical lesions. This unique solution consists of a photosensitizer with a 100-fold increase in absorption capacity, a 635-nanometer wavelength, and a low-power 7-milliwatt LED red light, all integrated into a portable photodynamic therapy system for cervical health. This novel treatment is poised to transform the “one-size-fits-all” surgical approach to managing precancerous cervical lesions.
Innovative Solution to Preserve Women’s Fertility and Cervical Health, Enabling Fertility-Friendly Cervical Cancer Prevention Strategies
Treating precancerous cervical lesions is a crucial step in preventing cervical cancer. Yet, surgery, as the current go-to option, often brings serious side effects, including bleeding, infection, and damage to cervical structure. It can further lead to preterm birth, miscarriage, and compromised fertility, impacting women’s quality of life. There is an urgent need for non-invasive treatment options that preserve cervical health and safeguard fertility.
The introduction of APL-1702 marks a meaningful shift from the one-size-fits-all surgical approach to a non-invasive alternative. This innovative treatment brings new hope to patients by potentially reversing disease progression while preserving the cervix, lowering recurrence risks, and supporting long-term management of precancerous conditions. Most importantly, it offers a pathway for women to retain their fertility, addressing a major concern and brightening their future.
In the recent directive Several Measures to Accelerate the Improvement of the Fertility Support Policy System to Promote the Construction of a Fertility-Friendly Society, the State Council emphasizes the importance of achieving balanced fertility rates and fostering high-quality population development. APL-1702 stands out as a key component in this comprehensive cervical cancer prevention strategy. By aligning top-tier medical solutions with population development objectives, it will contribute to China’s fertility-friendly approach to cervical cancer prevention, which aims to accelerate cancer elimination while protecting women’s fertility.
Dr. Kevin Pan, founder, chairman, and CEO of Asieris Hong Kong, said, “As a global innovative pharmaceutical company, we are thrilled to showcase our groundbreaking product APL-1702 at this year’s China International Import Expo. The expo serves as a premium platform to demonstrate global innovations and technologies, and provides unparalleled opportunities for growth companies like ours. We look forward to leveraging the spillover effect of the CIIE to fast-track APL-1702’s launch in China, benefiting more patients sooner and contributing to China’s goals of cervical cancer elimination and the development of a fertility-friendly society.”
Note: As of this release date, APL-1702 has yet to be approved in China and is presented solely for display at the 2024 China International Import Expo. The information provided is not intended for patients. For more details about the condition, please consult a healthcare professional.
Årets mest spennende pressemelding fra Asieris som omhandler Photocure/Cevira slik jeg ser det.
10 Likes
Asieris Unveils Results for the First Time at 2024 IPVC the Analysis of the of HPV Clearance Rate for Different HPV Types and Different Follow-up Times of the Non-Surgical Treatment for Cervical HSIL Product APL-1702 Clinical Study
Shanghai, China, November 12, 2024 – Asieris Pharmaceuticals (Stock Code: 688176.SH), a global biopharmaceutical leader in the discovery, development, and commercialization of innovative drugs for genitourinary tumors and related diseases, announced that the international multicenter phase III clinical study data of its non-surgical treatment for cervical High-Grade Squamous Intraepithelial Lesion (HSIL) product APL-1702 has been published by the 2024 International Papillomavirus Conference (IPVC) as a poster, focusing on the analysis data of HPV clearance rate for different HPV types and different follow-up times.
This study is a prospective, randomized, double blind, placebo controlled, multicenter phase Ⅲ clinical study, which has reached its primary efficacy endpoint and exhibited good safety.
Furthermore, this study found that the baseline HPV clearance rate and the HPV16/18 clearance rate in the APL-1702 group at the 6th month were significantly better than those in the placebo group, as detailed below:
| Subgroup Analysis | APL-1702 Group | PBO Group | P Value |
|---|---|---|---|
| Baseline HPV Clearance | 29.4% | 18.9% | 0.04 |
| HPV16/18-Positive Clearance Rate | 31.4% | 15.4% | 0.01 |
At 3 and 6months, the positive rates of different subgroups of HPV in the APL-1702 group were lower than those in the placebo group, suggesting that the APL-1702 group had a faster rate of HPV clearance and that the HPV clearance persisted at 12 months after merely 1-2 treatments, as shown in the below:
The new drug application for APL-1702 was accepted by the National Medical Products Administration (NMPA) in May 2024. The review process is progressing smoothly.
18 Likes
" Stronger than expected P&L figures
Photocure released its 3Q report this morning. Revenues were reported at NOK 120.2m vs NOK 117.7m estimated by us (2% deviation). This reflects a 12% YoY increase (-3% QoQ). In the U.S., revenues increased by 12% YoY, supported by higher average pricing, while in-market unit sales grew by 6% YoY. In Europe, revenue grew also by 12% YoY, driven primarily by strong performance in Germany and Priority Growth Markets, with in-market unit sales rising 9% YoY. Adj. EBITDA came in at NOK 5.0m, surpassing our estimate of NOK 3.7m, largely due to well-contained operating expenses. Reported EPS beat our estimate at NOK -0.13, marking an improvement from the NOK -0.18 figure recorded in the same period last year. The company’s balance sheet was robust with NOK 291m in cash and equivalents, up from NOK 260m at year-end 2023." (sier Norne)
8 Likes