YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 339 drug applications between 18 November 2023 and 24 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 98, covering 70 drug names.
2023/11/18 – 2023/11/24
- New acceptances this week
- 339
- Drugs with new generic filings (by drug name, de-duplicated)
- 70
- Accepted this week, now under review
- 1
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
339filings, 98 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 158 |
| Generic | 98 |
| New drug | 52 |
| Import | 15 |
| Unspecified | 10 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 243 |
| TCM | 57 |
| Therapeutic biologic | 31 |
| Biologic | 6 |
| Prophylactic biologic | 2 |
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 | Potassium Chloride Granules | 4 | 2 | 4 |
| 2 | Brivaracetam Tablets | 4 | 1 | 19 |
| 3 | Latamoxef Sodium for Injection | 3 | 1 | 1 |
| 4 | Iohexol Injection | 3 | 1 | 5 |
| 5 | Dabigatran Etexilate Capsules | 3 | 1 | 2 |
| 6 | Esmolol Hydrochloride Injection | 2 | 2 | 3 |
| 7 | Tacrolimus Sustained-release Capsules | 2 | 1 | 6 |
| 8 | Gabapentin Capsules | 2 | 1 | 0 |
| 9 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 10 | Flumazenil Injection | 2 | 1 | 2 |
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
219 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Sichuan Jin Xin Kang Da Pharmaceuticals Technology Co., Ltd. romanized | 10 | 9 | 0 |
| 2 | Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized | 7 | 7 | 0 |
| 3 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 6 | 1 | 0 |
| 4 | Eli Lilly and Company | 5 | 1 | 0 |
| 5 | GUERBET | 5 | 1 | 0 |
| 6 | Novo Nordisk A/S | 5 | 1 | 0 |
| 7 | Shandong Jing Hui Bio Technology Co., Ltd. romanized | 4 | 2 | 4 |
| 8 | Fresenius Kabi Austria GmbH | 4 | 1 | 0 |
| 9 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 4 | 1 | 4 |
| 10 | Ferring GmbH | 3 | 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
103 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/11/24Generic · Class 3 | Fudosteine oral solutionCYHS2303253 | Jiangsu Kai Yuan Pharma Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2023/11/24Generic · Class 3 | Potassium Chloride InjectionCYHS2303251 | Beijing Bu Lin Bio Technology Co., Ltd. romanized; Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2023/11/24Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2303246 | Hebei Dong Sheng Ke Yu Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized |
| 2023/11/24Generic · Class 3 | Potassium Chloride GranulesCYHS2303245 | Guizhou Rui He Pharmaceutical Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized |
| 2023/11/24Generic · Class 3 | Potassium Chloride GranulesCYHS2303244 | Guizhou Rui He Pharmaceutical Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized |
| 2023/11/24Generic · Class 3 | 复方匹可硫酸钠颗粒 · No verified English nameCYHS2303242 | Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Shijiazhuang Yu Hui Pharmaceutical Co., Ltd. romanized |
| 2023/11/24Generic · Class 3 | Flumazenil InjectionCYHS2303241 | Shanghai Xu Dong Hai Pu Pharma Co., Ltd. romanized |
| 2023/11/24Generic · Class 3 | Flumazenil InjectionCYHS2303240 | Shanghai Xu Dong Hai Pu Pharma Co., Ltd. romanized |
| 2023/11/24Generic · Class 3 | 聚乙二醇3350散 · No verified English nameCYHS2303239 | Shu Tai Shen (Beijing) Biopharmaceutical Co., Ltd. romanized |
| 2023/11/24New drug · Class 1.1 | 辛芪通鼻片 · No verified English nameCXZS2300024 | Beijing Yi Ling Pharma Co., Ltd. romanized; Shijiazhuang Yi Ling Pharma Co., Ltd. romanized |
| 2023/11/24New drug · Class 1 | B013注射液 · No verified English nameCXSL2300807 | Shanghai Shang Yao Jiao Lian Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/24New drug · Class 1 | GR2102注射液 · No verified English nameCXSL2300806 | Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized; Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized |
| 2023/11/24New drug · Class 1 | GR1802注射液 · No verified English nameCXSL2300805 | Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized |
| 2023/11/24New drug · Class 1 | 福泽雷塞片 · No verified English nameCXHS2300105 | Xin Da Bio Technology Co., Ltd. romanized; Kang Long Hua Cheng (Ningbo) Technology Development Co., Ltd. romanized |
| 2023/11/24New drug · Class 1 | 注射用CEND-1 · No verified English nameCXHL2301310 | Qilu Pharmaceutical Co., Ltd. |
| 2023/11/24New drug · Class 2.4; 2.2 | BH011注射液 · No verified English nameCXHL2301309 | Zhuhai Bei Hai Bio Technology Co., Ltd. romanized |
| 2023/11/23Import · Class 1 | CagriSema注射液 · No verified English nameJXSL2300201 | Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd |
| 2023/11/23Import · Class 1 | CagriSema注射液 · No verified English nameJXSL2300200 | Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd |
| 2023/11/23Import · Class 1 | CagriSema注射液 · No verified English nameJXSL2300199 | Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd |
| 2023/11/23Import · Class 1 | CagriSema注射液 · No verified English nameJXSL2300198 | Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd |
| 2023/11/23Import · Class 1 | CagriSema注射液 · No verified English nameJXSL2300197 | Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd |
| 2023/11/23Generic · Class 3 | Ferrous Succinate TabletsCYHS2303234 | Rui Yang Pharmaceutical Co., Ltd. romanized |
| 2023/11/23Generic · Class 3 | Potassium Chloride GranulesCYHS2303232 | Zhejiang Bai Ao Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/11/23Generic · Class 3 | Potassium Chloride GranulesCYHS2303231 | Zhejiang Bai Ao Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/11/23Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2303224 | Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized |
| 2023/11/23Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2303223 | Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized |
| 2023/11/23Generic · Class 3 | Latamoxef Sodium for InjectionCYHS2303221 | Shandong Jing Hui Bio Technology Co., Ltd. romanized; Shandong Run Ze Pharmaceutical Co., Ltd. romanized |
| 2023/11/23Generic · Class 3 | Latamoxef Sodium for InjectionCYHS2303220 | Shandong Jing Hui Bio Technology Co., Ltd. romanized; Shandong Run Ze Pharmaceutical Co., Ltd. romanized |
| 2023/11/23Generic · Class 3 | Latamoxef Sodium for InjectionCYHS2303219 | Shandong Jing Hui Bio Technology Co., Ltd. romanized; Shandong Run Ze Pharmaceutical Co., Ltd. romanized |
| 2023/11/23New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2300804 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
73 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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