YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 19 drug applications between 22 January 2023 and 28 January 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 3, covering 3 drug names.
2023/01/22 – 2023/01/28
- New acceptances this week
- 19
- Drugs with new generic filings (by drug name, de-duplicated)
- 3
- Accepted this week, now under review
- 0
DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.
Names with a public page are linked.
New acceptances this week
By application type and drug type
19filings, 3 of them generic
By application type
| Application type | Filings |
|---|---|
| New drug | 9 |
| Supplement | 4 |
| Generic | 3 |
| Import re-registration | 2 |
| Import | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 12 |
| Therapeutic biologic | 4 |
| TCM | 3 |
DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.
Most new generic filings, by drug
3 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 氟比洛芬凝胶贴膏 · No verified English name | 1 | 1 | 16 |
| 2 | Ademetionine 1,4 - Butanedisulfonate For Injection | 1 | 1 | 2 |
| 3 | Neratinib Maleate Tablets | 1 | 1 | 0 |
DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.
Most new acceptances, by company
17 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized | 2 | 2 | 0 |
| 2 | Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized | 2 | 1 | 0 |
| 3 | Gilead Sciences Inc. | 1 | 1 | 0 |
| 4 | Gilead Sciences Ireland UC | 1 | 1 | 0 |
| 5 | Merck Sharp & Dohme LLC | 1 | 1 | 0 |
| 6 | Shanghai Xin Yi Jin Zhu Pharma Co., Ltd. romanized | 1 | 1 | 0 |
| 7 | Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized | 1 | 1 | 0 |
| 8 | Beijing Ying Ke Rui Innovation Drug Research Co., Ltd. romanized | 1 | 1 | 0 |
| 9 | Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized | 1 | 1 | 0 |
| 10 | Jilin Ao Dong Tao Nan Pharma Co., Ltd. romanized | 1 | 1 | 0 |
DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.
Under-review list changes
Compared across this platform's snapshots of the under-review list
Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.
DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.
Class 3 and new-drug acceptances
10 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/01/28Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSS2300013 | Merck Sharp & Dohme LLC; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd |
| 2023/01/28New drug · Class 3.1 | 枇杷清肺颗粒 · No verified English nameCXZS2300004 | Jilin Ao Dong Tao Nan Pharma Co., Ltd. romanized |
| 2023/01/28New drug · Class 2.2 | 小儿豉翘清热糖浆 · No verified English nameCXZS2300003 | Ji Chuan Pharma Group Co., Ltd. romanized |
| 2023/01/28New drug · Class 1.1 | 杞菊颗粒 · No verified English nameCXZL2300004 | Beijing Ying Ke Rui Innovation Drug Research Co., Ltd. romanized |
| 2023/01/28New drug · Class 1 | JAB-BX300注射液 · No verified English nameCXSL2300062 | Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized |
| 2023/01/28New drug · Class 1 | 重组抗PD-1全人源单克隆抗体注射液 · No verified English nameCXSL2300061 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2023/01/28New drug · Class 1 | NFS-02眼用注射液 · No verified English nameCXSL2300060 | Wuhan Niu Fu Si Bio Technology Co., Ltd. romanized; Niu Fu Si (Suzhou) Bio Technology Co., Ltd. romanized |
| 2023/01/28New drug · Class 2.2 | BH009注射液 · No verified English nameCXHL2300113 | Zhuhai Bei Hai Bio Technology Co., Ltd. romanized |
| 2023/01/28New drug · Class 2.4 | 注射用多西他赛(白蛋白结合型) · No verified English nameCXHL2300112 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2023/01/28New drug · Class 2.2 | HD-NE02缓释滴眼液 · No verified English nameCXHL2300111 | Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized |
DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.