YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 279 drug applications between 15 October 2021 and 21 October 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 47, covering 32 drug names.
2021/10/15 – 2021/10/21
- New acceptances this week
- 279
- Drugs with new generic filings (by drug name, de-duplicated)
- 32
- 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
279filings, 47 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 155 |
| Generic | 47 |
| New drug | 46 |
| Import | 14 |
| Import re-registration | 9 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 206 |
| Therapeutic biologic | 35 |
| TCM | 29 |
| Prophylactic biologic | 5 |
| Biologic | 4 |
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
32 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Fluconazole for Oral Suspension | 4 | 1 | 0 |
| 2 | 阿普米司特片 · No verified English name | 3 | 1 | 3 |
| 3 | Valsartan and Amlodipine Tablets(I) | 2 | 2 | 2 |
| 4 | Dimethyl Fumarate Delayed-release Capsules | 2 | 1 | 0 |
| 5 | Empagliflozin Tablets | 2 | 1 | 18 |
| 6 | Fluconazole and Sodium Chloride Injection | 2 | 1 | 1 |
| 7 | Tranexamic Acid Injection | 2 | 1 | 11 |
| 8 | Meropenem for Injection | 2 | 1 | 5 |
| 9 | Sodium Hyaluronate Eye Drops | 2 | 1 | 30 |
| 10 | Dopamine Hydrochloride Injection | 2 | 1 | 3 |
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
149 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanized | 23 | 11 | 0 |
| 2 | Gansu Fu Ge Zang Yao Co., Ltd. romanized | 9 | 9 | 0 |
| 3 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 9 | 5 | 0 |
| 4 | Shanxi Wan Hui Pharmaceutical Co., Ltd. romanized | 7 | 5 | 0 |
| 5 | Fo Shan De Rui Ke Pharmaceutical Co., Ltd. romanized | 5 | 1 | 0 |
| 6 | Eli Lilly and Company | 4 | 3 | 0 |
| 7 | Hui Rui Pharmaceutical Technology Co., Ltd. romanized | 4 | 3 | 0 |
| 8 | Bioverativ Therapeutics Inc | 4 | 1 | 0 |
| 9 | NAPP PHARMACEUTICALS LIMITED | 4 | 1 | 0 |
| 10 | Takeda Pharmaceutical Company Limited | 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
72 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/10/21Import · Class 2.1 | OAV101注射液 · No verified English nameJXSL2101118 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd |
| 2021/10/21Import · Class 1 | 注射用MRX-8 · No verified English nameJXHL2101212 | MicuRx Pharmaceuticals Inc.; Name not romanized |
| 2021/10/21Import · Class 1 | venglustat · No verified English nameJXHL2101211 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd |
| 2021/10/21Import · Class 1 | venglustat · No verified English nameJXHL2101210 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd |
| 2021/10/21Generic · Class 3 | Tranexamic Acid InjectionCYHS2101906 | Peng Lai Nuo Kang Pharma Co., Ltd. romanized |
| 2021/10/21Generic · Class 3 | Tranexamic Acid InjectionCYHS2101905 | Peng Lai Nuo Kang Pharma Co., Ltd. romanized |
| 2021/10/21Generic · Class 3 | Ibuprofen Lysine InjectionCYHS2101904 | Sichuan Wei Ao Pharmaceutical Co., Ltd. romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2021/10/21Generic · Class 3 | Amlodipine Besylate and Benazepril Hydrochloride CapsulesCYHS2101902 | Yang Zi Jiang Pharma Group Guangzhou Hai Rui Pharma Co., Ltd. romanized |
| 2021/10/21Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2101900 | Jilin Zhen Ao Pharmaceutical Co., Ltd. romanized |
| 2021/10/21Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2101899 | Jilin Zhen Ao Pharmaceutical Co., Ltd. romanized |
| 2021/10/21Generic · Class 3 | Calcium Gluconate InjectionCYHS2101857 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2021/10/21Generic · Class 3 | Pregabalin Oral SolutionCYHS2101844 | Hefei En Rui Te Pharma Co., Ltd. romanized |
| 2021/10/21New drug · Class 2.2 | 注射用重组人尿激酶原 · No verified English nameCXSS2101040 | Tian Shi Li Biopharmaceuticals Co., Ltd. romanized |
| 2021/10/21New drug · Class 1 | 重组人源化抗表皮生长因子受体单克隆抗体注射液 · No verified English nameCXSL2101379 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized |
| 2021/10/21New drug · Class 1 | 重组抗PD-1全人源单克隆抗体注射液 · No verified English nameCXSL2101378 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2021/10/21New drug · Class 1 | TQB2450注射液 · No verified English nameCXSL2101363 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2021/10/21New drug · Class 1 | 安纳拉唑钠肠溶片 · No verified English nameCXHS2101049 | Xuan Zhu (Beijing) Pharmaceuticals Technology Co., Ltd. romanized; Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized |
| 2021/10/21New drug · Class 2.4 | 甲苯磺酸多纳非尼片 · No verified English nameCXHS2101048 | Name not romanized |
| 2021/10/21New drug · Class 1 | 注射用TB001 · No verified English nameCXHL2101590 | Qing Yuan Shi Tu Wei An Chuang Technology Kai Fa Co., Ltd. romanized |
| 2021/10/21New drug · Class 1 | JYP0322片 · No verified English nameCXHL2101589 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/10/21New drug · Class 1 | JYP0322片 · No verified English nameCXHL2101588 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/10/21New drug · Class 1 | 注射用TB001 · No verified English nameCXHL2101587 | Qing Yuan Shi Tu Wei An Chuang Technology Kai Fa Co., Ltd. romanized |
| 2021/10/21New drug · Class 2.4 | 注射用多西他赛(白蛋白结合型) · No verified English nameCXHL2101586 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2021/10/21New drug · Class 1 | SCR-6852胶囊 · No verified English nameCXHL2101584 | Xian Sheng Pharma Co., Ltd. romanized |
| 2021/10/21New drug · Class 1 | SCR-6852胶囊 · No verified English nameCXHL2101583 | Xian Sheng Pharma Co., Ltd. romanized |
| 2021/10/21New drug · Class 2.2 | SYHX2011 · No verified English nameCXHL2101581 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2021/10/21New drug · Class 2.2; 2.4 | 注射用醋酸丙氨瑞林微球 · No verified English nameCXHL2101573 | Shanghai Li Zhu Pharmaceutical Co., Ltd. romanized |
| 2021/10/20New drug · Class 1 | 注射用RS2102 · No verified English nameCXSL2101376 | Rui Shi Biopharmaceuticals Co., Ltd. romanized |
| 2021/10/19Import · Class 3.1 | 替拉珠单抗注射液 · No verified English nameJXSS2101026 | Sun Pharma Global FZE; Vetter Pharma-Fertigung GmbH & Co. KG; Shenzhen Kangzhe Biotechnology Co. Ltd. |
| 2021/10/19Import · Class 1 | SAR442168 · No verified English nameJXHL2101209 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
42 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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