YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 342 drug applications between 16 December 2023 and 22 December 2023 (data as of 14 November 2026 06:00). Of these, generic applications numbered 95, covering 71 drug names.
2023/12/16 – 2023/12/22
- New acceptances this week
- 342
- Drugs with new generic filings (by drug name, de-duplicated)
- 71
- 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
342filings, 95 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 147 |
| Generic | 95 |
| New drug | 67 |
| Import | 17 |
| Unspecified | 8 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 238 |
| TCM | 59 |
| Therapeutic biologic | 40 |
| Biologic | 3 |
| In vitro diagnostic reagent | 1 |
| Prophylactic biologic | 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
71 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 | 58 |
| 4 | Sacubitril Valsartan Sodium Tablets | 3 | 2 | 70 |
| 5 | Cetitizine Hydrochloride Oral Solution | 3 | 2 | 6 |
| 6 | Ceftazidime And Avibactam Sodium For Injection | 2 | 2 | 11 |
| 7 | Brimonidine Tartrate Eye Drops | 2 | 2 | 4 |
| 8 | Progesterone Sustained-release Vaginal Gel | 2 | 2 | 2 |
| 9 | Diquafosol Sodium Eye Drops | 2 | 1 | 5 |
| 10 | Levofloxacin and Sodium Chloride Injection | 2 | 1 | 14 |
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 | Shanxi Ren Yuan Tang Pharma Co., Ltd. romanized | 13 | 13 | 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 | Novartis Pharma Schweiz AG | 4 | 2 | 0 |
| 8 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | Chengdu Brilliant Pharmaceutical Co., Ltd. | 4 | 2 | 0 |
| 10 | Heilongjiang Bo Yu Pharmaceutical Co., Ltd. romanized | 4 | 2 | 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
113 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2023/12/22New drug · Class 1 | LM-108注射液 · No verified English nameCXSL2300879 | Shanghai Li Xin Pharmaceuticals Research and Development Co., Ltd. romanized |
| 2023/12/22New drug · Class 2.4 | 注射用BAT1006 · No verified English nameCXSL2300878 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2023/12/22New drug · Class 1 | 重组抗CD20人源化单克隆抗体皮下注射液 · No verified English nameCXSL2300877 | Shanghai Shang Yao Jiao Lian Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/12/22New drug · Class 1 | 注射用BAT7205 · No verified English nameCXSL2300876 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2023/12/22New drug · Class 1 | SR604注射液 · No verified English nameCXSL2300875 | Shanghai Lai Shi Xue Ye Zhi Pin Co., Ltd. romanized |
| 2023/12/22New drug · Class 1 | HDM1005注射液 · No verified English nameCXHL2301440 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2023/12/22New drug · Class 1 | HDM1005注射液 · No verified English nameCXHL2301439 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2023/12/22New drug · Class 1 | HDM1005注射液 · No verified English nameCXHL2301438 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2023/12/22New drug · Class 1 | HDM1005注射液 · No verified English nameCXHL2301437 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2023/12/22New drug · Class 1 | ANG-0623胶囊 · No verified English nameCXHL2301436 | Jia Xing He Ji Pharma Co., Ltd. romanized |
| 2023/12/22New drug · Class 1 | ANG-0623胶囊 · No verified English nameCXHL2301435 | Jia Xing He Ji Pharma Co., Ltd. romanized |
| 2023/12/22New drug · Class 1 | 伊匹乌肽滴眼液 · No verified English nameCXHL2301434 | Yi Cheng Kang Tai (Xiamen) Bio Technology Co., Ltd. romanized |
| 2023/12/22New drug · Class 2.4 | GPN00884滴眼液 · No verified English nameCXHL2301433 | Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized; Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized |
83 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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