YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 336 drug applications between 3 September 2023 and 9 September 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 69, covering 55 drug names.
2023/09/03 – 2023/09/09
- New acceptances this week
- 336
- Drugs with new generic filings (by drug name, de-duplicated)
- 55
- 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
336filings, 69 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 178 |
| Generic | 69 |
| New drug | 40 |
| Import re-registration | 23 |
| Import | 20 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 248 |
| TCM | 62 |
| Therapeutic biologic | 20 |
| 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
55 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Amoxicillin Sodium for Injection | 5 | 2 | 0 |
| 2 | Lidocaine and Prilocaine Cream | 2 | 2 | 24 |
| 3 | 复方聚乙二醇电解质散(儿童型) · No verified English name | 2 | 2 | 2 |
| 4 | Formoterol Fumarate Inhalation Solution | 2 | 2 | 5 |
| 5 | Pentoxifylline Injection | 2 | 2 | 3 |
| 6 | Eltrombopag Olamine Tablets | 2 | 2 | 1 |
| 7 | Metaraminol Tartrate Injection | 2 | 2 | 2 |
| 8 | Phloroglucinol Injection | 2 | 2 | 2 |
| 9 | Nicorandil for Injection | 2 | 1 | 1 |
| 10 | Bromfenac Sodium Eye Drops | 2 | 1 | 7 |
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
205 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | NAPP PHARMACEUTICALS LIMITED | 15 | 1 | 0 |
| 2 | Haerbin Tong Yi Tang Pharma Co., Ltd. romanized | 11 | 11 | 0 |
| 3 | Shanxi Zhen Dong Wu He Tang Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Shen Wei Pharma Group Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Eli Lilly and Company | 6 | 1 | 0 |
| 6 | Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized | 5 | 3 | 0 |
| 9 | Guangxi Zhuang Zu Zi Zhi Qu Drug Research Institute Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Guizhou Rui He Pharmaceutical Co., Ltd. romanized | 4 | 3 | 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
84 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/09/09Import · Class 1 | GDC-9545 · No verified English nameJXHL2300209 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2023/09/09Generic · Class 3 | Pentoxifylline InjectionCYHS2302430 | Hainan Pu Li Pharmaceutical Co., Ltd. romanized |
| 2023/09/09Generic · Class 3 | 复方匹可硫酸钠颗粒 · No verified English nameCYHS2302428 | Jiangxi Ke Rui Pharma Co., Ltd. romanized |
| 2023/09/09Generic · Class 3 | Epalrestat TabletsCYHS2302427 | Hebei Rui Sen Pharma Co., Ltd. romanized |
| 2023/09/09Generic · Class 3 | Indobufen TabletsCYHS2302426 | Beijing Wei Lin Heng Chang Pharmaceuticals Technology Co., Ltd. romanized; Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2023/09/09New drug · Class 3.3 | 西妥昔单抗注射液 · No verified English nameCXSS2300075 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2023/09/09New drug · Class 1 | HSK36357胶囊 · No verified English nameCXHL2300971 | Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2023/09/09New drug · Class 1 | HSK36357胶囊 · No verified English nameCXHL2300970 | Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2023/09/09New drug · Class 2.2 | 盐酸达泊西汀口溶膜 · No verified English nameCXHL2300969 | Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized |
| 2023/09/09New drug · Class 1 | 注射用XCCS605B · No verified English nameCXHL2300968 | Shanghai Hua Yu Bio Technology Co., Ltd. romanized |
| 2023/09/08Import · Class 2.2 | 度伐利尤单抗注射液 · No verified English nameJXSS2300078 | AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca Investment (China) Co. Ltd. |
| 2023/09/08Import · Class 2.2 | 度伐利尤单抗注射液 · No verified English nameJXSS2300077 | AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca Investment (China) Co. Ltd. |
| 2023/09/08Import · Class 1 | LY3502970胶囊 · No verified English nameJXHL2300208 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/09/08Import · Class 1 | LY3502970胶囊 · No verified English nameJXHL2300207 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/09/08Import · Class 1 | LY3502970胶囊 · No verified English nameJXHL2300206 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/09/08Import · Class 1 | LY3502970胶囊 · No verified English nameJXHL2300205 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/09/08Import · Class 1 | LY3502970胶囊 · No verified English nameJXHL2300204 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/09/08Import · Class 1 | LY3502970胶囊 · No verified English nameJXHL2300203 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/09/08Generic · Class 3 | Piperacillin Sodium for InjectionCYHS2302423 | Hunan Bai Qi He Drug Research and Development Co., Ltd. romanized; Jiangsu Hai Hong Pharmaceutical Co., Ltd. romanized |
| 2023/09/08Generic · Class 3 | Potassium Chloride GranulesCYHS2302422 | Chongqing Xin He Bio Technology Co., Ltd. romanized; Chongqing Ke Rui Nan Hai Pharmaceutical Co., Ltd. romanized |
| 2023/09/08Generic · Class 3 | 复方聚乙二醇电解质散(儿童型) · No verified English nameCYHS2302421 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2023/09/08Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2302417 | Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized |
| 2023/09/08Generic · Class 3 | Amoxicillin Sodium for InjectionCYHS2302414 | Sichuan Pharmaceutical Formulations Co., Ltd. romanized |
| 2023/09/08Generic · Class 3 | Amoxicillin Sodium for InjectionCYHS2302413 | Sichuan Pharmaceutical Formulations Co., Ltd. romanized |
| 2023/09/08Generic · Class 3 | Amoxicillin Sodium for InjectionCYHS2302412 | Sichuan Pharmaceutical Formulations Co., Ltd. romanized |
| 2023/09/08Generic · Class 3 | 复方维生素C聚乙二醇(3350)钠钾散 · No verified English nameCYHS2302411 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. |
| 2023/09/08New drug · Class 1.1 | 双参苓颗粒 · No verified English nameCXZL2300060 | Beijing Ying Ke Rui Innovation Drug Research Co., Ltd. romanized |
| 2023/09/08New drug · Class 2.2 | Meloxicam injectionCXHS2300077 | Nanjing Qing Pu Bio Technology Co., Ltd. romanized; Nanjing Jian You Sheng Hua Pharmaceutical Co., Ltd. romanized |
| 2023/09/08New drug · Class 2.4 | 西罗莫司口服溶液 · No verified English nameCXHL2300967 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2023/09/07Import · Class 1 | AGN-151586 · No verified English nameJXSL2300164 | AbbVie Inc.; Allergan Information Consulting (Shanghai) Co. Ltd |
54 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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