YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 386 drug applications between 6 September 2023 and 12 September 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 75, covering 62 drug names.
2023/09/06 – 2023/09/12
- New acceptances this week
- 386
- Drugs with new generic filings (by drug name, de-duplicated)
- 62
- 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
386filings, 75 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 196 |
| Generic | 75 |
| New drug | 53 |
| Import | 35 |
| Import re-registration | 20 |
| Unspecified | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 293 |
| TCM | 56 |
| Therapeutic biologic | 31 |
| Prophylactic biologic | 5 |
| In vitro diagnostic reagent | 1 |
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
62 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Amoxicillin Sodium for Injection | 3 | 1 | 0 |
| 2 | Lidocaine and Prilocaine Cream | 2 | 2 | 24 |
| 3 | 吸入用布地奈德混悬液 · No verified English name | 2 | 2 | 7 |
| 4 | 复方聚乙二醇电解质散(儿童型) · No verified English name | 2 | 2 | 2 |
| 5 | Formoterol Fumarate Inhalation Solution | 2 | 2 | 5 |
| 6 | Pentoxifylline Injection | 2 | 2 | 3 |
| 7 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 2 | 2 | 23 |
| 8 | Famotidine Injection | 2 | 1 | 8 |
| 9 | Nicorandil for Injection | 2 | 1 | 1 |
| 10 | Oxacillin Sodium for Injection | 2 | 1 | 13 |
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
212 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | NAPP PHARMACEUTICALS LIMITED | 15 | 1 | 0 |
| 2 | Boehringer Ingelheim International GmbH | 14 | 1 | 0 |
| 3 | Haerbin Tong Yi Tang Pharma Co., Ltd. romanized | 11 | 11 | 0 |
| 4 | Xian Jing Xi Shuang He Pharma Co., Ltd. romanized | 7 | 2 | 0 |
| 5 | Changchun Jin Sai Pharma Co., Ltd. romanized | 7 | 2 | 0 |
| 6 | Shanxi Zhen Dong Wu He Tang Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 7 | Shen Wei Pharma Group Co., Ltd. romanized | 6 | 6 | 0 |
| 8 | Jiangsu En Hua Pharma Co., Ltd. romanized | 6 | 3 | 1 |
| 9 | Eli Lilly and Company | 6 | 1 | 0 |
| 10 | Shanghai Bai Te Medical Yong Pin Co., Ltd. romanized | 6 | 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
116 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/09/12Import · Class 1 | GSK1070806注射液 · No verified English nameJXSL2300169 | GlaxoSmithKline Intellectual Property Development Limited; GlaxoSmithKline (China) Investment Co. LTD |
| 2023/09/12Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2300223 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/12Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2300222 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/12Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2300221 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/12Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2300220 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/12Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2300219 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/12Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2300218 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/12Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2300217 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/12Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2300216 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/12Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2300215 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/12Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2300214 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/12Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2300213 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/12Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2300212 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/12Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2300211 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/12Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2300210 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/12Generic · Class 3 | 聚乙二醇4000散(儿童型) · No verified English nameCYHS2302460 | Jin Nuo Kang Pharma Technology (Shijiazhuang) Co., Ltd. romanized; Shijiazhuang Yu Hui Pharmaceutical Co., Ltd. romanized |
| 2023/09/12Generic · Class 3 | Oxacillin Sodium for InjectionCYHS2302452 | Chongqing Shi Li De Pharmaceuticals Technology Co., Ltd. romanized; Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized |
| 2023/09/12Generic · Class 3 | Oxacillin Sodium for InjectionCYHS2302451 | Chongqing Shi Li De Pharmaceuticals Technology Co., Ltd. romanized; Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized |
| 2023/09/12Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2302450 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2023/09/12Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2302449 | Su Zhou Yi Fan Pharma Co., Ltd. romanized |
| 2023/09/12Generic · Class 3 | Multiple Electrolyte Additive For InjectionCYHS2302447 | Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized |
| 2023/09/12Generic · Class 3 | Famotidine InjectionCYHS2302446 | Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2023/09/12Generic · Class 3 | Famotidine InjectionCYHS2302445 | Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2023/09/12New drug · Class 3.2 | 重组人促卵泡激素-CTP融合蛋白注射液 · No verified English nameCXSL2300612 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2023/09/12New drug · Class 3.2 | 重组人促卵泡激素-CTP融合蛋白注射液 · No verified English nameCXSL2300611 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2023/09/12New drug · Class 2.2 | 重组人促卵泡激素-CTP融合蛋白注射液 · No verified English nameCXSL2300610 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2023/09/12New drug · Class 2.2 | 重组人促卵泡激素-CTP融合蛋白注射液 · No verified English nameCXSL2300609 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2023/09/12New drug · Class 1 | LNF1802单克隆抗体注射液 · No verified English nameCXSL2300608 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2023/09/12New drug · Class 1 | LNF1901单克隆抗体注射液 · No verified English nameCXSL2300607 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2023/09/12New drug · Class 1 | REV001注射液 · No verified English nameCXSL2300606 | Shanghai Xing Shen Bio Technology Co., Ltd. romanized |
86 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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