YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 186 drug applications between 22 September 2021 and 28 September 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 25, covering 18 drug names.
2021/09/22 – 2021/09/28
- New acceptances this week
- 186
- Drugs with new generic filings (by drug name, de-duplicated)
- 18
- 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
186filings, 25 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 109 |
| New drug | 31 |
| Generic | 25 |
| Import | 8 |
| Unspecified | 7 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 129 |
| Therapeutic biologic | 29 |
| TCM | 23 |
| Biologic | 4 |
| 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
18 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Clindamycin Injection | 3 | 1 | 4 |
| 2 | Esomeprazole Magnesium for Delayed-release Oral Suspension | 3 | 1 | 4 |
| 3 | Dopamine Hydrochloride Injection | 2 | 2 | 3 |
| 4 | Ibuprofen Suspension | 2 | 1 | 14 |
| 5 | Felodipine Sustained Release Tablets | 2 | 1 | 1 |
| 6 | Compound α-Ketoacid Tablets | 1 | 1 | 0 |
| 7 | Levofloxacin and Sodium Chloride Injection | 1 | 1 | 14 |
| 8 | Levofloxacin Tablets | 1 | 1 | 7 |
| 9 | Posaconazole Oral Suspension | 1 | 1 | 3 |
| 10 | Roxatidine Acetate Hydrochloride For Injection | 1 | 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
95 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanized | 17 | 8 | 0 |
| 2 | Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized | 10 | 1 | 0 |
| 3 | Sai Ling Pharma Technology Group Co., Ltd. romanized | 9 | 8 | 0 |
| 4 | Kyowa Kirin Co. Ltd | 6 | 1 | 0 |
| 5 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized | 6 | 1 | 0 |
| 6 | Hubei Ye Zhen Tang Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 2 | 0 |
| 8 | Bristol-Myers Squibb Pharma EEIG | 5 | 1 | 0 |
| 9 | Upjohn US 2 LLC | 4 | 1 | 0 |
| 10 | AstraZeneca AB | 3 | 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
47 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/09/26Import · Class 1 | VAY736注射液 · No verified English nameJXSL2101110 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2021/09/26Import · Class 2.4 | Vericiguat片 · No verified English nameJXHL2101186 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2021/09/26Import · Class 2.4 | Vericiguat片 · No verified English nameJXHL2101185 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2021/09/26Import · Class 2.4 | Vericiguat片 · No verified English nameJXHL2101184 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2021/09/26Import · Class 1 | LOU064片 · No verified English nameJXHL2101183 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2021/09/26Generic · Class 3 | Clindamycin InjectionCYHS2101784 | Jilin Si Huan Pharmaceutical Co., Ltd. romanized |
| 2021/09/26Generic · Class 3 | Clindamycin InjectionCYHS2101783 | Jilin Si Huan Pharmaceutical Co., Ltd. romanized |
| 2021/09/26Generic · Class 3 | Clindamycin InjectionCYHS2101782 | Jilin Si Huan Pharmaceutical Co., Ltd. romanized |
| 2021/09/26Generic · Class 3 | Compound α-Ketoacid TabletsCYHS2101780 | Zhejiang AngLiKang Pharmaceutical CO.,LTD. |
| 2021/09/26Generic · Class 3 | Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2101779 | Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized; Qingdao Bai Yang Pharmaceutical Co., Ltd. romanized |
| 2021/09/26Generic · Class 3 | Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2101778 | Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized; Qingdao Bai Yang Pharmaceutical Co., Ltd. romanized |
| 2021/09/26Generic · Class 3 | Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2101777 | Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized; Qingdao Bai Yang Pharmaceutical Co., Ltd. romanized |
| 2021/09/26Generic · Class 3 | Roxatidine Acetate Hydrochloride For InjectionCYHS2101771 | Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized |
| 2021/09/26Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2101770 | Hong He Pharmaceutical Co., Ltd. romanized; Jilin Si Huan Pharmaceutical Co., Ltd. romanized |
| 2021/09/26New drug · Class 2.3 | 荆防合剂 · No verified English nameCXZL2101027 | Lu Nan Hou Pu Pharmaceutical Co., Ltd. romanized |
| 2021/09/26New drug · Class 1 | 凯得宁单抗注射液 · No verified English nameCXSS2101032 | Kang Fang Pharma Co., Ltd. romanized; Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2021/09/26New drug · Class 1 | 斯鲁利单抗注射液 · No verified English nameCXSL2101343 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized |
| 2021/09/26New drug · Class 1 | 重组人源化抗PD-1单克隆抗体注射液 · No verified English nameCXSL2101342 | Tai Zhou Han Zhong Biopharmaceuticals Co., Ltd. romanized |
| 2021/09/26New drug · Class 1 | 注射用MRG002 · No verified English nameCXSL2101341 | Shanghai Mei Ya Ke Bio Technology Co., Ltd. romanized |
| 2021/09/26New drug · Class 1 | CG-BM1异体人骨髓间充质干细胞注射液 · No verified English nameCXSL2101334 | Guangzhou Sai Juan Bio Technology Co., Ltd. romanized |
| 2021/09/26New drug · Class 1 | LVGN6051单克隆抗体注射液 · No verified English nameCXSL2101332 | Li Jin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2021/09/26New drug · Class 1 | KL290052胶囊 · No verified English nameCXHL2101510 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2021/09/26New drug · Class 1 | KL290052胶囊 · No verified English nameCXHL2101509 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2021/09/26New drug · Class 1 | IPG1094片 · No verified English nameCXHL2101508 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/09/26New drug · Class 1 | IPG1094片 · No verified English nameCXHL2101507 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/09/26New drug · Class 1 | IPG1094片 · No verified English nameCXHL2101506 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/09/26New drug · Class 2.4 | 硫酸阿托品滴眼液 · No verified English nameCXHL2101505 | Hangzhou He Er Si Technology Co., Ltd. romanized |
| 2021/09/26New drug · Class 1 | IPG1094片 · No verified English nameCXHL2101504 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/09/26New drug · Class 1 | IPG1094片 · No verified English nameCXHL2101503 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/09/26New drug · Class 1 | IPG1094片 · No verified English nameCXHL2101502 | Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized |
17 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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