YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 329 drug applications between 17 December 2023 and 23 December 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 97, covering 70 drug names.
2023/12/17 – 2023/12/23
- New acceptances this week
- 329
- Drugs with new generic filings (by drug name, de-duplicated)
- 70
- Accepted this week, now under review
- 3
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
329filings, 97 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 133 |
| Generic | 97 |
| New drug | 60 |
| Import | 20 |
| Unspecified | 11 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 227 |
| TCM | 61 |
| Therapeutic biologic | 34 |
| Biologic | 3 |
| Prophylactic biologic | 3 |
| 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
70 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Lactulose Oral Solution | 4 | 3 | 34 |
| 2 | Carboplatin Injection | 4 | 2 | 10 |
| 3 | Vonoprazan Fumarate Tablets | 4 | 2 | 60 |
| 4 | Sacubitril Valsartan Sodium Tablets | 3 | 2 | 70 |
| 5 | Cetitizine Hydrochloride Oral Solution | 3 | 2 | 6 |
| 6 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 2 | 2 | 23 |
| 7 | Ceftazidime And Avibactam Sodium For Injection | 2 | 2 | 12 |
| 8 | Brimonidine Tartrate Eye Drops | 2 | 2 | 4 |
| 9 | Progesterone Sustained-release Vaginal Gel | 2 | 2 | 2 |
| 10 | Diquafosol Sodium Eye Drops | 2 | 1 | 5 |
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
207 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shanxi Ren Yuan Tang Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 2 | AstraZeneca AB | 7 | 3 | 0 |
| 3 | Guizhou Bai Ling Qi Ye Group Pharmaceutical Co., Ltd. romanized | 6 | 3 | 0 |
| 4 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 6 | 2 | 0 |
| 5 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 5 | 2 | 0 |
| 6 | Hainan Xu Wo Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 8 | Chengdu Brilliant Pharmaceutical Co., Ltd. | 4 | 2 | 0 |
| 9 | Patheon France | 4 | 1 | 0 |
| 10 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized | 4 | 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
107 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/12/23Import · Class 1 | Aficamten片 · No verified English nameJXHL2300325 | Cytokinetics Incorporated; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd |
| 2023/12/23Import · Class 2.4 | 布地格福吸入气雾剂 · No verified English nameJXHL2300324 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2023/12/23Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2303591 | Guangdong Jiang Zheng Pharma Co., Ltd. romanized; Tian Da Pharma (Zhuhai) Co., Ltd. romanized |
| 2023/12/23Generic · Class 3 | Potassium Chloride InjectionCYHS2303590 | Jiangxi Bo Tai Pharma Co., Ltd. romanized; Jiangxi Dong Fu Pharmaceutical Co., Ltd. romanized |
| 2023/12/23Generic · Class 3 | Potassium Chloride InjectionCYHS2303589 | Jiangxi Bo Tai Pharma Co., Ltd. romanized; Jiangxi Dong Fu Pharmaceutical Co., Ltd. romanized |
| 2023/12/23Generic · Class 3 | 复方聚乙二醇电解质散(II) · No verified English nameCYHS2303588 | Heilongjiang Bo Yu Pharmaceutical Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2023/12/23Generic · Class 3 | 复方聚乙二醇电解质散(II) · No verified English nameCYHS2303587 | Heilongjiang Bo Yu Pharmaceutical Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2023/12/23New drug · Class 1.4 | 24价肺炎球菌多糖结合疫苗 · No verified English nameCXSL2300887 | Beijing Ke Xing Zhong Wei Bio Technology Co., Ltd. romanized; Beijing Ke Xing Bio Zhi Pin Co., Ltd. romanized |
| 2023/12/23New drug · Class 1.4 | 24价肺炎球菌多糖结合疫苗 · No verified English nameCXSL2300886 | Beijing Ke Xing Zhong Wei Bio Technology Co., Ltd. romanized; Beijing Ke Xing Bio Zhi Pin Co., Ltd. romanized |
| 2023/12/23New drug · Class 1 | FL115注射液 · No verified English nameCXSL2300885 | Suzhou Fu Rong Bio Technology Co., Ltd. romanized |
| 2023/12/23New drug · Class 1 | LP-005 注射液 · No verified English nameCXSL2300884 | Tian Chen Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2023/12/23New drug · Class 1 | LP-003 注射液 · No verified English nameCXSL2300883 | Tian Chen Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2023/12/23New drug · Class 1 | LP-005 注射液 · No verified English nameCXSL2300882 | Tian Chen Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2023/12/22Import · Class 2.2 | 注射用Tafasitamab · No verified English nameJXSL2300233 | Incyte Biosciences Distribution B.V.; Beijing InnoCare Pharma Tech Co. Ltd. |
| 2023/12/22Import · Class 1 | DS-1062a · No verified English nameJXSL2300232 | Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited |
| 2023/12/22Import · Class 1 | Zilurgisertib片 · No verified English nameJXHL2300323 | Incyte Corporation; Incyte Biosciences Shanghai Co. Ltd. |
| 2023/12/22Import · Class 2.4 | Osimertinib Mesylate TabletsJXHL2300322 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/12/22Import · Class 2.4 | Osimertinib Mesylate TabletsJXHL2300321 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/12/22Import · Class 2.4 | Osimertinib Mesylate TabletsJXHL2300320 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2023/12/22Import · Class 2.4 | Osimertinib Mesylate TabletsJXHL2300319 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2023/12/22Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2303577 | Shandong Yi Kang Pharma Co., Ltd. romanized |
| 2023/12/22Generic · Class 3 | Dobutamine Hydrochloride InjectionCYHS2303576 | Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized |
| 2023/12/22Generic · Class 3 | Ketorolac Tromethamine InjectionCYHS2303575 | Chongqing Lai Mei Pharma Co., Ltd. romanized |
| 2023/12/22Generic · Class 3 | Ketorolac Tromethamine InjectionCYHS2303574 | Chongqing Lai Mei Pharma Co., Ltd. romanized |
| 2023/12/22Generic · Class 3 | Metoprolol Tartrate InjectionCYHS2303566 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2023/12/22Generic · Class 3 | 烟酸缓释片 · No verified English nameCYHS2303564 | Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized |
| 2023/12/22Generic · Class 3 | 烟酸缓释片 · No verified English nameCYHS2303563 | Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized |
| 2023/12/22Generic · Class 3 | Fosaprepitant Dimeglumine for InjectionCYHL2300156 | Hunan Sai Long Pharma Co., Ltd. romanized |
| 2023/12/22New drug · Class 1 | 注射用BAT8010 · No verified English nameCXSL2300881 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2023/12/22New drug · Class 1 | ALXN2220注射液 · No verified English nameCXSL2300880 | A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized |
77 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.
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.