YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 350 drug applications between 13 September 2023 and 19 September 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 70, covering 52 drug names.
2023/09/13 – 2023/09/19
- New acceptances this week
- 350
- Drugs with new generic filings (by drug name, de-duplicated)
- 52
- 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
350filings, 70 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 190 |
| Generic | 70 |
| New drug | 51 |
| Import | 16 |
| Unspecified | 13 |
| Import re-registration | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 244 |
| TCM | 61 |
| Therapeutic biologic | 37 |
| Prophylactic biologic | 8 |
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
52 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sodium Valproate Sustained-release Tablets(I) | 2 | 2 | 4 |
| 2 | Diprophylline Injection | 2 | 2 | 7 |
| 3 | Calcium Folinate Injection | 2 | 2 | 4 |
| 4 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 2 | 2 | 23 |
| 5 | Tacrolimus Ointment | 2 | 1 | 6 |
| 6 | 利伐沙班颗粒 · No verified English name | 2 | 1 | 2 |
| 7 | Celecoxib Tablets | 2 | 1 | 3 |
| 8 | Omeprazole and Sodium Bicarbonate Capsules | 2 | 1 | 0 |
| 9 | Pregabalin Oral Solution | 2 | 1 | 5 |
| 10 | Vortioxetine Hydrobromide Tablets | 2 | 1 | 10 |
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
202 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Henan Yue Ren Pharma Co., Ltd. romanized | 12 | 12 | 0 |
| 2 | Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized | 12 | 9 | 0 |
| 3 | Henan Shuang He Hua Li Pharma Co., Ltd. romanized | 12 | 3 | 0 |
| 4 | Bard Pharmaceuticals Limited | 8 | 8 | 0 |
| 5 | Boehringer Ingelheim International GmbH | 7 | 1 | 0 |
| 6 | Xian Jing Xi Shuang He Pharma Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | Guangxi Shi Wan Shan Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Hebei Wan Bang Fu Lin Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Novartis Pharma Schweiz AG | 5 | 2 | 0 |
| 10 | Jiangsu Fei Sen You Si Pharmaceuticals Yong Pin Co., Ltd. romanized | 4 | 4 | 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
95 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/09/19Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2300235 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/19Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2300234 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/19Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2300233 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/19Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2300232 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/19Generic · Class 3 | Diprophylline InjectionCYHS2302525 | Shaanxi Dun Si Pharmaceutical Co., Ltd. romanized |
| 2023/09/19Generic · Class 3 | 水合氯醛灌肠剂 · No verified English nameCYHS2302523 | Chengdu Shuo De Pharma Co., Ltd. romanized |
| 2023/09/19Generic · Class 3 | 复方匹可硫酸钠颗粒 · No verified English nameCYHS2302522 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2023/09/19Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2302519 | Sui Cheng Pharma Co., Ltd. romanized |
| 2023/09/19Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2302518 | Sui Cheng Pharma Co., Ltd. romanized |
| 2023/09/19Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2302510 | Nanjing Yi Teng Drug Research Institute Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2023/09/19Generic · Class 3 | Pentoxifylline InjectionCYHS2302509 | Da Yi Pharma (Hubei) Co., Ltd. romanized; Lang Tian Pharma (Hubei) Co., Ltd. romanized |
| 2023/09/19Generic · Class 3 | Celecoxib TabletsCYHS2302505 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2023/09/19Generic · Class 3 | Celecoxib TabletsCYHS2302504 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2023/09/19Generic · Class 3 | Diprophylline InjectionCYHS2302503 | Xizang Nuo Ze Biopharmaceuticals Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2023/09/19Generic · Class 3 | Methylnaltrexone Bromide TabletsCYHL2300119 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2023/09/19New drug · Class 1 | 注射用AP026 · No verified English nameCXSL2300632 | An Yuan Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/09/19New drug · Class 3.2 | UNODC0407注射液 · No verified English nameCXSL2300631 | Guangdong You Nuo Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/09/19New drug · Class 1 | 人脂肪间充质干细胞注射液 · No verified English nameCXSL2300630 | Beijing Ai Ge Gan Xi Bao Technology Co., Ltd. romanized |
| 2023/09/19New drug · Class 1 | CM313(SC)注射液 · No verified English nameCXSL2300629 | Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
| 2023/09/19New drug · Class 1 | JMKX003948片 · No verified English nameCXHL2301013 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized |
| 2023/09/19New drug · Class 1 | JMKX003948片 · No verified English nameCXHL2301012 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized |
| 2023/09/19New drug · Class 1 | JMKX003948片 · No verified English nameCXHL2301011 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized |
| 2023/09/19New drug · Class 2.2 | 氢溴酸右美沙芬硫酸奎尼丁口崩片 · No verified English nameCXHL2301010 | Beijing Kang Chuang Lian Biopharmaceutical Technology Research Co., Ltd. romanized |
| 2023/09/18Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2300231 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/18Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2300230 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/18Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2300229 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/18Import · Class 1 | LOXO-435片 · No verified English nameJXHL2300228 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/09/18Import · Class 1 | LOXO-435片 · No verified English nameJXHL2300227 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/09/17New drug · Class 1 | 艾帕洛利单抗注射液 · No verified English nameCXSS2300077 | Qilu Pharmaceutical Co., Ltd. |
| 2023/09/16Import · Class 2.4 | 米罗那非片 · No verified English nameJXHL2300226 | AriBio Co. Ltd.; Panacro (Hefei) Pharmaceutical Technology Co. Ltd. |
65 more not listed (at most 30 rows).
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.
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