YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 377 drug applications between 17 November 2023 and 23 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 97, covering 70 drug names.
2023/11/17 – 2023/11/23
- New acceptances this week
- 377
- Drugs with new generic filings (by drug name, de-duplicated)
- 70
- Accepted this week, now under review
- 4
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
377filings, 97 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 187 |
| Generic | 97 |
| New drug | 59 |
| Import | 16 |
| Unspecified | 10 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 265 |
| TCM | 65 |
| Therapeutic biologic | 39 |
| 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 | Brivaracetam Tablets | 4 | 1 | 19 |
| 2 | Latamoxef Sodium for Injection | 3 | 1 | 1 |
| 3 | Iohexol Injection | 3 | 1 | 5 |
| 4 | Dabigatran Etexilate Capsules | 3 | 1 | 2 |
| 5 | Metoclopramide Hydrochloride Injection | 2 | 2 | 6 |
| 6 | Esmolol Hydrochloride Injection | 2 | 2 | 3 |
| 7 | Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution | 2 | 2 | 8 |
| 8 | Tacrolimus Sustained-release Capsules | 2 | 1 | 6 |
| 9 | Gabapentin Capsules | 2 | 1 | 0 |
| 10 | Perindopril arginine and amlodipine besylate tablets | 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
239 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Novo Nordisk A/S | 10 | 2 | 0 |
| 2 | Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized | 8 | 8 | 0 |
| 3 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 7 | 2 | 0 |
| 4 | Shandong Er Ye Pharmaceutical Co., Ltd. romanized | 5 | 2 | 0 |
| 5 | Eli Lilly and Company | 5 | 1 | 0 |
| 6 | GUERBET | 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
106 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2023/11/23New drug · Class 1 | 重组人源化抗BTLA单克隆抗体注射液 · No verified English nameCXSL2300803 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/23New drug · Class 1 | 重组柯萨奇病毒B3注射液 · No verified English nameCXSL2300802 | Wuhan Bo Wei De Bio Technology Co., Ltd. romanized |
| 2023/11/23New drug · Class 1 | 注射用ACR246 · No verified English nameCXSL2300801 | Hangzhou Ai Ke Rui Si Biopharmaceuticals Co., Ltd. romanized |
| 2023/11/23New drug · Class 1 | EMB-01注射液 · No verified English nameCXSL2300800 | Shanghai An Mai Bio Technology Co., Ltd. romanized; An Mai Bio Technology (Suzhou) Co., Ltd. romanized |
| 2023/11/23New drug · Class 1 | HS-10398胶囊 · No verified English nameCXHL2301308 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/23New drug · Class 1 | HS-10398胶囊 · No verified English nameCXHL2301307 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/23New drug · Class 1 | HS-10398胶囊 · No verified English nameCXHL2301306 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/23New drug · Class 1 | HS-10398胶囊 · No verified English nameCXHL2301305 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/23New drug · Class 1 | HS-10398胶囊 · No verified English nameCXHL2301304 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/23New drug · Class 1 | HS-10398胶囊 · No verified English nameCXHL2301303 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/23New drug · Class 1 | GST-HG141片 · No verified English nameCXHL2301302 | Fujian Guang Sheng Zhong Lin Bio Technology Co., Ltd. romanized |
| 2023/11/23New drug · Class 1 | GST-HG141片 · No verified English nameCXHL2301301 | Fujian Guang Sheng Zhong Lin Bio Technology Co., Ltd. romanized |
| 2023/11/23New drug · Class 1 | 盐酸希美替尼片 · No verified English nameCXHL2301298 | Zhongguo Ke College Shanghai Drug Research Institute romanized; Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/23New drug · Class 1 | CG-7321胶囊 · No verified English nameCXHL2301297 | Name not romanized |
| 2023/11/23New drug · Class 1 | CG-7321胶囊 · No verified English nameCXHL2301296 | Name not romanized |
| 2023/11/22Import · Class 1 | HRO761 · No verified English nameJXHL2300295 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
76 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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