YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 341 drug applications between 16 November 2023 and 22 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 81, covering 60 drug names.
2023/11/16 – 2023/11/22
- New acceptances this week
- 341
- Drugs with new generic filings (by drug name, de-duplicated)
- 60
- 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
341filings, 81 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 187 |
| Generic | 81 |
| New drug | 46 |
| Import | 12 |
| Unspecified | 11 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 240 |
| TCM | 57 |
| Therapeutic biologic | 35 |
| Biologic | 7 |
| 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
60 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 | Iohexol Injection | 3 | 1 | 5 |
| 3 | Dabigatran Etexilate Capsules | 3 | 1 | 2 |
| 4 | Metoclopramide Hydrochloride Injection | 2 | 2 | 6 |
| 5 | Esmolol Hydrochloride Injection | 2 | 2 | 3 |
| 6 | Tacrolimus Sustained-release Capsules | 2 | 1 | 6 |
| 7 | Gabapentin Capsules | 2 | 1 | 0 |
| 8 | Perindopril arginine and amlodipine besylate tablets | 2 | 1 | 3 |
| 9 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 10 | Bupivacaine Hydrochloride Injection | 2 | 1 | 4 |
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
226 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 2 | Shandong Er Ye Pharmaceutical Co., Ltd. romanized | 5 | 2 | 0 |
| 3 | Eli Lilly and Company | 5 | 1 | 0 |
| 4 | GUERBET | 5 | 1 | 0 |
| 5 | Novo Nordisk A/S | 5 | 1 | 0 |
| 6 | Pfizer Europe MA EEIG | 4 | 2 | 0 |
| 7 | Guangzhou Yin Nuo Pharmaceuticals Group Co., Ltd. romanized | 4 | 1 | 0 |
| 8 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 4 | 1 | 4 |
| 9 | Ferring GmbH | 3 | 3 | 0 |
| 10 | Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized | 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
82 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/11/22Import · Class 1 | HRO761 · No verified English nameJXHL2300295 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2023/11/22Import · Class 1 | HRO761 · No verified English nameJXHL2300294 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2023/11/22Import · Class 1 | LNP023胶囊 · No verified English nameJXHL2300293 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2023/11/22Generic · Class 3 | Esmolol Hydrochloride InjectionCYHS2303214 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2023/11/22Generic · Class 3 | Piperacillin Sodium for InjectionCYHS2303212 | Shandong Jing Hui Bio Technology Co., Ltd. romanized; Shandong Rui Ying Pharmaceutical Group Co., Ltd. romanized |
| 2023/11/22Generic · Class 3 | Nefopam Hydrochloride InjectionCYHS2303211 | Guangzhou Ai Qi Xi Xin Yao Research Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2023/11/22Generic · Class 3 | Levetiracetam in Sodium Chloride InjectionCYHS2303210 | Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Name not romanized |
| 2023/11/22Generic · Class 3 | Nicorandil for InjectionCYHS2303209 | Chengdu Di Ao Jiu Hong Pharmaceutical Factory romanized; Chengdu Tong De Pharma Co., Ltd. romanized |
| 2023/11/22Generic · Class 3 | Bupivacaine Hydrochloride InjectionCYHS2303207 | Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized |
| 2023/11/22Generic · Class 3 | Bupivacaine Hydrochloride InjectionCYHS2303206 | Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized |
| 2023/11/22New drug · Class 1 | 注射用MHB039A · No verified English nameCXSL2300799 | Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2023/11/22New drug · Class 1 | 重组抗CD20人源化单克隆抗体皮下注射液 · No verified English nameCXSL2300798 | Shanghai Shang Yao Jiao Lian Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/22New drug · Class 1 | JMB2004注射液 · No verified English nameCXSL2300797 | Jiangsu Ji Ye Biopharmaceutical Co., Ltd. romanized |
| 2023/11/22New drug · Class 1.2 | 重组脊髓灰质炎疫苗(汉逊酵母) · No verified English nameCXSL2300796 | Guo Yao Zhong Sheng Bio Technology Research Institute Co., Ltd. romanized; Beijing Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2023/11/22New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2300795 | Zhejiang Quan Sheng Bio Technology Co., Ltd. romanized |
| 2023/11/22New drug · Class 1 | 泰莱替尼胶囊 · No verified English nameCXHS2300104 | Bao Yuan Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized |
| 2023/11/22New drug · Class 1 | SBK007片 · No verified English nameCXHL2301295 | Chengdu Shi Bei Kang Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/22New drug · Class 1 | NHWD-870 HCl片 · No verified English nameCXHL2301294 | Zhejiang Wen Da Pharmaceuticals Technology Co., Ltd. romanized; Hunan Heng Ya Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/22New drug · Class 1 | NHWD-870 HCl片 · No verified English nameCXHL2301293 | Zhejiang Wen Da Pharmaceuticals Technology Co., Ltd. romanized; Hunan Heng Ya Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/22New drug · Class 1 | FZ007-119片 · No verified English nameCXHL2301292 | Guangzhou Fei Mi Zi Technology Co., Ltd. romanized |
| 2023/11/22New drug · Class 1 | FZ007-119片 · No verified English nameCXHL2301291 | Guangzhou Fei Mi Zi Technology Co., Ltd. romanized |
| 2023/11/22New drug · Class 1 | YK1001MY片 · No verified English nameCXHL2301290 | Yao Kang Zhong Tuo (Beijing) Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/22New drug · Class 1 | YK1001MY片 · No verified English nameCXHL2301289 | Yao Kang Zhong Tuo (Beijing) Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/21Generic · Class 3 | Esmolol Hydrochloride InjectionCYHS2303200 | Jiangxi Yi You Pharma Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized |
| 2023/11/21Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2303190 | Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/11/21Generic · Class 3 | Famotidine InjectionCYHS2303189 | Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized |
| 2023/11/21Generic · Class 3 | 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2303184 | Guangdong Sai Kang Pharmaceutical Factory Co., Ltd. romanized |
| 2023/11/21Generic · Class 3 | Magnesium Sulfate InjectionCYHS2303181 | Jiao Zuo Shi Min Kang Pharma Co., Ltd. romanized |
| 2023/11/21Generic · Class 3 | Drotaverine Hydrochloride TabletsCYHS2303180 | Jiangsu Lianhuan Pharmaceutical Co.,Ltd. |
| 2023/11/21Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2303179 | An Sheng Pharma Co., Ltd. romanized; Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanized |
52 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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