YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 396 drug applications between 7 September 2023 and 13 September 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 83, covering 66 drug names.
2023/09/07 – 2023/09/13
- New acceptances this week
- 396
- Drugs with new generic filings (by drug name, de-duplicated)
- 66
- 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
396filings, 83 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 194 |
| Generic | 83 |
| New drug | 60 |
| Import | 31 |
| Import re-registration | 19 |
| Unspecified | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 298 |
| TCM | 54 |
| Therapeutic biologic | 37 |
| Prophylactic biologic | 6 |
| 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
66 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 | Formoterol Fumarate Inhalation Solution | 2 | 2 | 5 |
| 5 | Levocarnitine Oral Solution | 2 | 2 | 9 |
| 6 | Pentoxifylline Injection | 2 | 2 | 3 |
| 7 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 2 | 2 | 23 |
| 8 | 利伐沙班颗粒 · No verified English name | 2 | 1 | 2 |
| 9 | Pregabalin Oral Solution | 2 | 1 | 5 |
| 10 | Famotidine Injection | 2 | 1 | 8 |
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
224 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 | Xian Jing Xi Shuang He Pharma Co., Ltd. romanized | 9 | 2 | 0 |
| 4 | Changchun Jin Sai Pharma Co., Ltd. romanized | 7 | 2 | 0 |
| 5 | Haerbin Tong Yi Tang Pharma Co., Ltd. romanized | 6 | 6 | 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 | Eli Lilly and Company | 6 | 1 | 0 |
| 9 | Shanghai Bai Te Medical Yong Pin Co., Ltd. romanized | 6 | 1 | 0 |
| 10 | Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized | 5 | 5 | 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
125 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/09/13Generic · Class 3 | 利伐沙班颗粒 · No verified English nameCYHS2302484 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2023/09/13Generic · Class 3 | 利伐沙班颗粒 · No verified English nameCYHS2302483 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2023/09/13Generic · Class 3 | Paracetamol and Ibuprofen TabletsCYHS2302481 | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized |
| 2023/09/13Generic · Class 3 | 氯化钙注射液 · No verified English nameCYHS2302480 | Guangzhou He He Pharmaceuticals Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2023/09/13Generic · Class 3 | Fudosteine oral solutionCYHS2302476 | Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Zhejiang Guo Jing Pharma Co., Ltd. romanized |
| 2023/09/13Generic · Class 3 | Pentoxifylline Modified Release TabletsCYHS2302475 | Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Yong An Pharmaceutical Co., Ltd. romanized |
| 2023/09/13Generic · Class 3 | Pregabalin Oral SolutionCYHS2302471 | Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized |
| 2023/09/13Generic · Class 3 | Pregabalin Oral SolutionCYHS2302470 | Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized |
| 2023/09/13Generic · Class 3 | Adenosine InjectionCYHS2302469 | Sui Cheng Pharma Co., Ltd. romanized |
| 2023/09/13Generic · Class 3 | Adenosine InjectionCYHS2302468 | Sui Cheng Pharma Co., Ltd. romanized |
| 2023/09/13Generic · Class 3 | Carbazochrome Sodium Sulfonate TabletsCYHS2302466 | Chengdu Brilliant Pharmaceutical Co., Ltd. |
| 2023/09/13Generic · Class 3 | Memantine Hydrochloride Oral SolutionCYHS2302462 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED |
| 2023/09/13New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2300618 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2023/09/13New drug · Class 1 | 注射用SHR-A2009 · No verified English nameCXSL2300617 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2023/09/13New drug · Class 1 | F012 · No verified English nameCXSL2300616 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2023/09/13New drug · Class 2.5 | 冻干人用狂犬病疫苗(人二倍体细胞) · No verified English nameCXSL2300615 | Changchun Bai Ke Bio Technology Shareholding Company romanized |
| 2023/09/13New drug · Class 1 | 注射用重组人FGF21-Fc融合蛋白 · No verified English nameCXSL2300614 | An Yuan Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/09/13New drug · Class 1 | 注射用SHR-A1811 · No verified English nameCXSL2300613 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2023/09/13New drug · Class 1 | HSK16149胶囊 · No verified English nameCXHS2300081 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized; Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2023/09/13New drug · Class 1 | 安脑三醇注射液 · No verified English nameCXHL2300995 | Guangzhou Shi Sai Pu Te Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/09/13New drug · Class 2.2 | OD-03 · No verified English nameCXHL2300994 | Chongqing Ben Li Fang Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/09/13New drug · Class 1 | SH-337片 · No verified English nameCXHL2300993 | Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanized; Nanjing Shuo Hui Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/09/13New drug · Class 2.4 | 脯氨酸恒格列净片 · No verified English nameCXHL2300992 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/09/13New drug · Class 2.4 | 脯氨酸恒格列净片 · No verified English nameCXHL2300991 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/09/13New drug · Class 1 | HRS-8080片 · No verified English nameCXHL2300990 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2023/09/13New drug · Class 1 | HRS-8080片 · No verified English nameCXHL2300989 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2023/09/13New drug · Class 1 | 注射用QD202 · No verified English nameCXHL2300988 | Shanghai Kui Te Di Bio Technology Co., Ltd. romanized |
| 2023/09/13New drug · Class 1 | D-2570片 · No verified English nameCXHL2300987 | Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized |
| 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. |
95 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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