Cevira (APL‑1702) NMPA Review Status (as of Sep 2025)
Current NMPA Regulatory Status of Cevira (APL‑1702)
Cevira (APL-1702) remains under regulatory review by China’s National Medical Products Administration (NMPA) as of September 2025. It has not yet been approved or rejected . In May 2024, the NMPA formally accepted the New Drug Application (NDA) for Cevira, initiating the review processphotocure.com.
Since then, the review has progressed through at least one cycle of evaluation. In August 2025, Photocure and Asieris (Cevira’s developer in China) announced that Cevira’s NDA advanced to a second round of technical review , indicating that the first round of technical evaluation concluded with a request for additional information or clarificationsphotocure.com.
Asieris noted in its mid-2025 report that the review is “progressing smoothly” under this second technical evaluation roundasieris.com. No decision has been disclosed yet, and Cevira is effectively in the final stages of review prior to a potential approval. Both Photocure and Asieris have signaled optimism, with Asieris preparing for launch activities pending approvalasieris.com.
Key recent milestones: Cevira is a first-in-class photodynamic drug-device combination for non-surgical treatment of cervical HSIL (high-grade squamous intraepithelial lesions). Photocure out-licensed Cevira to Asieris in 2019, and Asieris completed a successful Phase III trial by September 2023photocure.comphotocure.com. The NDA acceptance in May 2024 was a major milestonephotocure.com. By August 2025 (roughly 15 months post-filing), the NMPA’s Center for Drug Evaluation (CDE) had moved Cevira into a second technical review cyclephotocure.com. This suggests that regulatory queries from the first review cycle have been addressed and the dossier is undergoing further evaluation . As of late September 2025, neither Asieris nor Photocure has announced final NMPA action, implying Cevira’s NDA is still under active review (i.e. not yet approved). There have been no indications of rejection; on the contrary, company statements emphasize continued progress and “proactive communication” with CDE to expedite the reviewphotocure.com.
NDA Review Timeline: Standard vs Actual vs Cevira’s Case
China’s standard NMPA review timeline for an NDA (marketing authorization application) is 200 working days by regulationenglish.nmpa.gov.cn. This roughly equates to about 9–10 months of review time under ideal conditions. For drugs granted priority review status (e.g. urgent clinical need or breakthrough therapies), the official timeline is accelerated to 130 working days (~6 months)english.nmpa.gov.cn. However, these timelines represent the targeted active review period by regulators, not guaranteed calendar time to approval . In real-world practice, the total time from NDA submission to approval in China often exceeds the statutory timeline , especially for complex or first-in-class products. Key comparisons include:
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Official NMPA Review Timeline (Standard) – ≈200 working days (about 9–10 months). This is the baseline for non-priority marketing applications as per Chinese regulationsenglish.nmpa.gov.cn. Notably, NMPA rules permit extending this timeline by up to 50% (an additional ~100 days) for special circumstancesenglish.nmpa.gov.cn, and certain periods (e.g. waiting for the company to submit supplemental data) are not counted toward the 200-day clockenglish.nmpa.gov.cn.
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Average Actual Approval Durations – Typically ~12–18 months . In practice, most novel drugs in China take about 1 to 1.5 years from NDA acceptance to approval , reflecting multiple review rounds and procedural pauses. Industry analyses and recent data support this range: for example, the median NDA approval time in 2017–2021 was about 15.4 months despite the formal 200-day targetlink.springer.com. Another analysis of oncology drugs found non-priority reviews averaging ~352 days (~11.6 months) vs. ~263 days with priority, and noted that China’s timelines still lag FDA benchmarkspmc.ncbi.nlm.nih.govpmc.ncbi.nlm.nih.gov. Overall, sources characterize China’s typical new drug approval timeline as roughly 1–2 years in totalpacificbridgemedical.com. Innovative biotech drugs or those requiring extensive review (like biologics or combination products) often skew toward the upper end of this range.
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Photocure’s Guidance (18-Month NDA Review) – Photocure has explicitly guided investors that NMPA reviews usually take on the order of ~18 months from submission to decisioncms.photocure.com. In its corporate presentations, Photocure noted that the Chinese authorities’ NDA review is “typically 18 months”cms.photocure.com. This 1.5-year estimate likely builds in expectations of clock-stops and additional steps beyond the 200-day core review. Indeed, Photocure’s own experience with Hexvix (another photodynamic drug) in China bore this out: Hexvix’s NDA was accepted in Nov 2023 and received approval by Nov 5, 2024 – about 12 months total, which Photocure considered an “early” approval relative to the usual 18-month timelinecms.photocure.comcms.photocure.com.
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Cevira’s NDA Timeline – Ongoing; >16 months in review (and counting) . Cevira’s NDA was accepted in mid-May 2024photocure.com. As of early August 2025, it entered a second review cycle, roughly ~15 months into the processphotocure.com. Now in late Sep 2025, ~17 months have elapsed since acceptance, and the review is still underway (pending outcome). This suggests Cevira’s timeline is tracking on the longer side (≥1.5 years) , consistent with Photocure’s 18-month expectation. The extended duration is not unusual given Cevira’s profile (first-in-class, drug-device combination) and the fact that multiple “technical review” rounds have been neededphotocure.com. The company statements imply that NMPA’s review clock was likely paused at least once for Asieris to provide additional data or analyses, after which the clock resumed for the next round of evaluation. The table below summarizes these timeline benchmarks:
| Review Timeline Reference |
Duration & Context |
| Standard NMPA review timeline |
~200 working days (≈9–10 months) for non-priority NDAsenglish.nmpa.gov.cn. Can be extended by 50% (up to 300 days) for complex casesenglish.nmpa.gov.cn. Excludes certain periods like applicant’s response time or inspection delaysenglish.nmpa.gov.cnenglish.nmpa.gov.cn. |
| Priority review timeline |
~130 working days (≈6–7 months) for qualifying drugsenglish.nmpa.gov.cn (e.g. urgent unmet need, breakthrough status). Cevira did not have priority designation, so the standard timeline applies. |
| Typical actual approval time (post-2017) |
~12–18 months for innovative drugs. Median ~15.4 months in 2017–21 after China’s reformslink.springer.com. Non-priority approvals often around 1+ year; first-in-class or complex applications can approach 1.5 years. |
| Photocure’s estimate for NMPA NDA |
~18 months . Photocure noted Chinese NDA reviews are “typically 18 Months”cms.photocure.com, reflecting the full process including pauses and ancillary steps. (Hexvix was approved in ~12 months, considered faster than averagecms.photocure.comcms.photocure.com.) |
| Cevira (APL-1702) NDA |
In progress (~16–17+ months so far) . NDA accepted May 12, 2024photocure.com; second-round technical review as of Aug 4, 2025photocure.com. Not yet approved as of Sep 2025. Timeline extended due to at least one Q&A cycle; final decision expected after ~1.5+ years of review. |
Why 200 Days vs 18 Months? – Factors Behind the Discrepancy
The contrast between the formal 200 working-day review target and a more protracted ~18-month real timeline can be explained by several procedural and practical factors. In China’s regulatory process (especially for a novel drug-device combo like Cevira), multiple steps and potential delays can add to the total calendar time:
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Clock Stops for Supplemental Information: The 200-day clock only counts active review time by the CDE , and it pauses whenever the sponsor must supply additional data or corrections . Under NMPA rules, any time used by the applicant to “supplement dossiers” or make required fixes is not included in the official timelineenglish.nmpa.gov.cn. In Cevira’s case, the initiation of a second review round implies that the CDE issued queries or deficiencies after the first round, and Asieris took time to respond before review resumedphotocure.com. These sponsor response periods can add weeks or months of real time, effectively extending the overall timeline.
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Multiple Technical Review Cycles: It is common for innovative or first-in-class NDAs to undergo more than one cycle of technical evaluation. Each “round” may conclude with questions, requiring a new cycle once the sponsor addresses them. Cevira’s NDA entering a second technical evaluation in Aug 2025 demonstrates this iterative processphotocure.com. Each additional review cycle means the 200-day review clock might be restarted or extended, pushing the approval decision further out.
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Manufacturing and GMP Inspections: Before approval, NMPA typically conducts GMP inspections of manufacturing sites (and in the case of combination products, possibly device production sites as well). Overseas inspections (e.g. if Cevira’s drug or device is produced outside China) can be logistically complex and time-consuming to schedule. Importantly, Chinese regulations stipulate that time spent on overseas site inspections is excluded from the 200-day review limit english.nmpa.gov.cn. Thus, if inspectors must visit a Photocure manufacturing facility in Europe or verify the device’s production, the scheduling and completion of those inspections can introduce significant calendar delays without “ticking” the official review clock.
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Regulatory Testing and Expert Panel Reviews: For a drug-device combination, NMPA may require additional testing or expert consultations . For example, the drug component might undergo verification testing, and the device component might need technical assessment or type certification . Recent guidelines require that for combination products, the medical device documentation be submitted separately for reviewbaipharm.chemlinked.com. While the primary mode (drug) dictates the pathway, the need to evaluate safety and performance of the device (light applicator) alongside the drug can lengthen the process. Moreover, first-in-class therapies may be referred to expert advisory committees for consultation, which can add scheduling time. All these steps – from lab testing to expert meetings – can pause or extend the review timeline.
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Use of Timeline Extensions: The NMPA’s framework allows regulators to formally extend the review timeline by up to 1/2 of the original duration for complex applicationsenglish.nmpa.gov.cn. In practice, this means a standard review can gain an extra 100 working days (~5 months) if needed. Such extensions are often invoked for novel products that require deeper evaluation. An 18-month total timeframe aligns with a scenario where the review period is extended and multiple cycles are involved.
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No Priority Designation: Cevira did not receive any accelerated review status, so it did not benefit from the shorter 130-day goal. It proceeded under the standard timeline, which inherently is longer. In contrast, life-threatening disease drugs or those with breakthrough status might get faster turnaround. Since HSIL (cervical pre-cancer) is an important condition but not an acute terminal illness, Cevira’s review likely proceeded in the normal queue, which can be slower.
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Innovative/Combination Nature: As a first-in-class therapy and a drug-device combination , Cevira represents new ground for regulators. Ensuring such a novel treatment meets all safety, efficacy, quality, and device performance standards may entail extra caution. Regulators may request more data analyses, require the sponsor to demonstrate training plans for device use, or consider post-market surveillance plans upfront. This thorough scrutiny, while beneficial for public health, generally translates to a longer review cycle compared to a routine drug approval. Photocure’s management acknowledged this reality by projecting ~18 months for approval, a buffer that accounts for these additional stepscms.photocure.com.
In summary, the oft-quoted “ 200 working days ” is the core technical review period, but real-world NDA approvals commonly span well beyond 200 days due to built-in pauses and ancillary procedures. The 18-month timeline mentioned by Photocure is not a contradiction of the regulations, but rather a realistic expectation that factors in multiple review rounds, sponsor reply times, mandatory inspections, and other procedural requirements that a complex product like Cevira must navigate. This discrepancy is typical – especially for pioneering therapies or combination products – and reflects China’s rigorous approach to ensure such novel treatments are properly vetted before approval.
Overall, as of September 2025, Cevira (APL-1702) is still under NMPA review (second technical evaluation round) and has not yet been approved photocure.com. Its review timeline has extended past the initial 200-day window into the anticipated ~1.5-year range, aligning with the broader trends for innovative drug approvals in Chinalink.springer.com. The extended timeline is attributable to the necessary thoroughness for a first-of-its-kind drug-device therapy, rather than any unusual setback. Both Asieris and Photocure expect a decision in due course and are preparing for a potential launch, pending NMPA’s final approval decisionasieris.com.
Sources:
- Photocure ASA – Press Release (Aug 4, 2025): Cevira NDA in China advanced to second round technical reviewphotocure.com.
- Asieris Pharmaceuticals – Semi-Annual Report 2025 (Aug 28, 2025): NDA review progressing, second-round technical evaluation initiatedasieris.com.
- Photocure ASA – Press Release (May 12, 2024): NMPA acceptance of Cevira NDA for reviewphotocure.com.
- NMPA (China) – Provisions for Drug Registration (2020): Standard review timelines (200 days standard, 130 days priority)english.nmpa.gov.cn; clock-stop and extension rulesenglish.nmpa.gov.cnenglish.nmpa.gov.cn.
- Photocure Corporate Presentation (June 2025): Commentary that NMPA NDA reviews typically take ~18 monthscms.photocure.com.
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Industry/Research Analyses: Recent study of China NDA approvals (2017–2021) showing median ~15.4 months timelinelink.springer.com; Pacific Bridge Medical overview noting ~1–2 year typical approval timespacificbridgemedical.com; oncology review indicating longer timelines without prioritypmc.ncbi.nlm.nih.gov.
Sitater
Photocure Partner Asieris announces New Drug Application acceptance for regulatory review of Cevira in China
https://www.photocure.com/news/photocure-partner-asieris-announces-new-drug-application-acceptance-for-regulatory-review-of-cevira-in-china-4817264
Asieris: Cevira (APL-1702) NDA Advances to Second Round of Technical Review
https://www.photocure.com/news/asieris-cevira-apl-1702-nda-advances-to-second-round-of-technical-review-5186151
Asieris Pharmaceuticals Releases 2025 Semi-Annual Report with Sustained Commercial Momentum and Breakthrough Innovation Poised for Launch - Asieris Pharmaceuticals
https://asieris.com/asieris-pharmaceuticals-releases-2025-semi-annual-report-with-sustained-commercial-momentum-and-breakthrough-innovation-poised-for-launch/
Asieris: Cevira (APL-1702) NDA Advances to Second Round of Technical Review
https://www.photocure.com/news/asieris-cevira-apl-1702-nda-advances-to-second-round-of-technical-review-5186151
Photocure Partner Asieris announces New Drug Application acceptance for regulatory review of Cevira in China
https://www.photocure.com/news/photocure-partner-asieris-announces-new-drug-application-acceptance-for-regulatory-review-of-cevira-in-china-4817264
Asieris: Cevira (APL-1702) NDA Advances to Second Round of Technical Review
https://www.photocure.com/news/asieris-cevira-apl-1702-nda-advances-to-second-round-of-technical-review-5186151
Provisions for Drug Registration
https://english.nmpa.gov.cn/2022-06/30/c_785628_8.htm
Provisions for Drug Registration
https://english.nmpa.gov.cn/2022-06/30/c_785628_8.htm
Provisions for Drug Registration
https://english.nmpa.gov.cn/2022-06/30/c_785628_8.htm
Trends and Characteristics of New Drug Approvals in China, 2011–2021 | Therapeutic Innovation & Regulatory Science
https://link.springer.com/article/10.1007/s43441-022-00472-3
Regulatory and clinical outcomes of priority-reviewed innovative cancer drugs in China between 2015 and 2024: an observational study - PMC
https://pmc.ncbi.nlm.nih.gov/articles/PMC12261532/
Regulatory and clinical outcomes of priority-reviewed innovative cancer drugs in China between 2015 and 2024: an observational study - PMC
https://pmc.ncbi.nlm.nih.gov/articles/PMC12261532/
Navigate China’s Drug Approval Process | PBM
https://www.pacificbridgemedical.com/resources/navigating-chinas-drug-approval-process-key-steps-for-success/
https://cms.photocure.com/uploads/Photocure_Corporate_Presentation_June_2025_737a1922ed.pdf
https://cms.photocure.com/uploads/Photocure_Corporate_Presentation_June_2025_737a1922ed.pdf
Provisions for Drug Registration
https://english.nmpa.gov.cn/2022-06/30/c_785628_8.htm
China Releases New Guidelines for Drug Registration Review, Effective March 2025 | ChemLinked
https://baipharm.chemlinked.com/news/china-releases-new-guidelines-for-drug-registration-review-effective-march-2025
