Priority review was introduced in 2017. Drugs need to meet three conditions to be eligible for this program: they must be new drugs with apparent clinical benefits, medicinal products for the prevention and treatment of certain conditions, or other medicinal products that are urgently needed and that meet the criteria, including consistency evaluation.
The priority review system seeks to solve the problematic delay in approvals when China is compared to other countries (‘drug lag’), as well as to deal with the backlog of applications. Drugs that have apparent clinical benefit have accounted for between 23% and 61% of all priority reviews in each of the past four years. During 2016–2020 period, the median review time for drugs and products granted priority review was 77 days
Conditional approval was introduced in 2020). The conditional authorized approval procedure had, however, been previously applied for drugs and vaccines before 2020. The procedure allows drugs or vaccines to be approved with surrogate endpoints or single arm trials if they have shown significant clinical efficacy. Several PD-1 inhibitors, such as sintilimab, [camrelizumab], and [tislelizumab]were approved for relapsed and/or refractory [classical Hodgkin lymphoma] (cHL) patients on the basis of single-arm phase 2 [clinical trials] with ORR ranging from 76.9% to 78.7%. [Niraparib] was approved as a maintenance treatment for platinum-sensitive refractory [ovarian cancer]patients on the basis of the results of global multicenter trials.
In the newly released China Women’s Development Guidelines (2021–2030), China clearly identified objectives including raising women’s awareness of cervical cancer prevention and treatment, continuously improving the prevention and treatment capacity for cervical cancer, and achieving 70% screening coverage of targeted female age groups (6). To effectively achieve these objectives, several strategies and measures were also recommended as follows (…)
Third, China should continue to implement women’s cervical cancer screening programs and comprehensively accelerate the improvement of cervical cancer screening rates among women.
Fourth, China has to strengthen innovative applications of cervical cancer screening and diagnostic technologies, explore screening methods and strategies suitable for China, focus on improving the screening and service capacities of local institutions, strengthen the building of information management systems and big data applications, and strengthen quality control, monitoring, and evaluation.
Finally, China needs to improve the tracking and management of those with abnormal screening results, strengthen the connectivity between screening and follow-up diagnosis and treatment services, and promote early diagnosis and treatment
it has been found that the provision of basic services in cervical cancer (vaccination, screening, and treatment) is still lacking
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APL-1702 is a pioneering cold light photodynamic drug-device combination product, used as a non-surgical therapy for treating cervical HSIL.
The response rate in the APL-1702 treatment group showed a statistically significant improvement of 89.4% (41.1% vs. 21.7%, p = 0.0001) compared to that in the placebo control group, indicating a remarkable therapeutic effect.
Women with cervical precancerous lesions have unmet clinical needsfor non-surgical therapies. Currently, invasive procedures such as loop electrosurgical excision procedure (LEEP) and cold knife conization remain the primary treatment options for high-grade cervical lesions. However, these surgical treatments are associated with adverse reactions including bleeding, infection, and cervical structural damage, which may lead to complications such as preterm birth and miscarriage.
Treating HSIL serves as the final barrier against cervical cancer.
I have encountered many HSIL patients who desire to preserve their intact cervix while receiving treatment. The emergence of APL-1702 will fulfill the wishes of these patients, allowing them to avoid or delay cervical trauma to the maximum extent possible
It is gratifying to see the emergence of innovative products like APL-1702, which simultaneously possess clinical value in addressing the treatment gap, public health value in cervical cancer prevention and control, and social value in promoting fertility-friendly options. This breakthrough will safeguard women’s health and make a positive contribution to the acceleration of the 2030 global and Chinese action plans for cervical cancer elimination
The study not only demonstrates remarkable efficacy but also exhibits a favorable safety profile, offering a new powerful artillery for the national cervical cancer prevention and control system.
Det blir et spennende Q2 - thats for sure.