YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 419 drug applications between 20 April 2023 and 26 April 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 86, covering 60 drug names.
2023/04/20 – 2023/04/26
- New acceptances this week
- 419
- Drugs with new generic filings (by drug name, de-duplicated)
- 60
- 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
419filings, 86 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 211 |
| Generic | 86 |
| New drug | 68 |
| Import | 28 |
| Import re-registration | 16 |
| Unspecified | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 303 |
| TCM | 57 |
| Therapeutic biologic | 53 |
| Biologic | 2 |
| Prophylactic biologic | 2 |
| In vitro diagnostic reagent | 1 |
| Drug-device combination | 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
60 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Iodixanol Injection | 8 | 1 | 0 |
| 2 | 恩那度司他片 · No verified English name | 3 | 1 | 0 |
| 3 | Sitagliptin and Metformin Hydrochloride Extended-release Tablets | 3 | 1 | 12 |
| 4 | 氧 · No verified English name | 2 | 2 | 15 |
| 5 | Lornoxicam for Injection | 2 | 2 | 2 |
| 6 | Isosorbide Dinitrate Injection | 2 | 2 | 0 |
| 7 | 硫酸特布他林雾化吸入用溶液 · No verified English name | 2 | 2 | 1 |
| 8 | Sugammadex Sodium Injection | 2 | 2 | 6 |
| 9 | Procaterol Hydrochloride Solution for Inhalation | 2 | 1 | 2 |
| 10 | 复方醋酸钠林格注射液 · No verified English name | 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
222 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Changsha Ai Bei Gao Pharma Co., Ltd. romanized | 22 | 17 | 0 |
| 2 | Anhui Xian Gui Pharmaceuticals Technology Co., Ltd. romanized | 14 | 14 | 0 |
| 3 | Heilongjiang Hua Xi Biopharmaceuticals Technology Co., Ltd. romanized | 9 | 9 | 0 |
| 4 | Zhejiang Guo Jing Pharma Co., Ltd. romanized | 9 | 2 | 0 |
| 5 | Sichuan He Li Xin Jian Pharma Co., Ltd. romanized | 8 | 6 | 0 |
| 6 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 8 | 3 | 0 |
| 7 | Tong Yong Dian Qi Pharma (Shanghai) Co., Ltd. romanized | 8 | 1 | 8 |
| 8 | Roche Pharma (Schweiz) AG | 6 | 2 | 0 |
| 9 | Celgene Corporation | 6 | 1 | 0 |
| 10 | Yan Tai Chuang He Bio Technology Co., Ltd. romanized | 6 | 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
133 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/04/26Import · Class 2.2 | 比吉利珠单抗注射液 · No verified English nameJXSS2300033 | UCB Pharma S.A.; UCB Trading (Shanghai) Co. Ltd |
| 2023/04/26Import · Class 2.2 | 比吉利珠单抗注射液 · No verified English nameJXSS2300032 | UCB Pharma S.A.; UCB Trading (Shanghai) Co. Ltd |
| 2023/04/26Import · Class 2.1 | 阿柏西普眼内注射溶液 · No verified English nameJXSL2300080 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2023/04/26Import · Class 1 | RO7434656注射液 · No verified English nameJXHL2300098 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2023/04/26Import · Class 1 | BLU-5937片 · No verified English nameJXHL2300097 | Bellus Health Cough Inc.; George (Beijing) Clinical Research Co. Ltd. |
| 2023/04/26Import · Class 1 | BLU-5937片 · No verified English nameJXHL2300096 | Bellus Health Cough Inc.; George (Beijing) Clinical Research Co. Ltd. |
| 2023/04/26Generic · Class 3 | Diazepam Rectal GelCYHS2301173 | Te Feng Pharmaceutical Co., Ltd. romanized |
| 2023/04/26Generic · Class 3 | Procaterol Hydrochloride Oral SolutionCYHS2301170 | Nanjing Ai De Jia Biopharmaceutical Technology Co., Ltd. romanized; Shanxi Tong Da Pharma Co., Ltd. romanized |
| 2023/04/26Generic · Class 3 | Procaterol Hydrochloride Oral SolutionCYHS2301169 | Nanjing Ai De Jia Biopharmaceutical Technology Co., Ltd. romanized; Shanxi Tong Da Pharma Co., Ltd. romanized |
| 2023/04/26Generic · Class 3 | 磷酸奥司他韦颗粒 · No verified English nameCYHS2301164 | Hubei Kang Yuan Pharma Co., Ltd. romanized; Hubei Zhong Gu Biopharmaceutical Co., Ltd. romanized |
| 2023/04/26New drug · Class 1 | 重组人源化抗PCSK9单克隆抗体注射液 · No verified English nameCXSS2300025 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized |
| 2023/04/26New drug · Class 1 | 重组人源化抗PCSK9单克隆抗体注射液 · No verified English nameCXSS2300024 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized |
| 2023/04/26New drug · Class 1 | 重组人源化抗PCSK9单克隆抗体注射液 · No verified English nameCXSS2300023 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized |
| 2023/04/26New drug · Class 1 | 重组人源化抗PCSK9单克隆抗体注射液 · No verified English nameCXSS2300022 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized |
| 2023/04/26New drug · Class 1 | 重组抗BCMA和CD3双特异性抗体注射液 · No verified English nameCXSL2300287 | Hua Lan Ji Yin Gong Cheng (Henan) Co., Ltd. romanized |
| 2023/04/26New drug · Class 1 | 普卢格列汀片 · No verified English nameCXHS2300048 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2023/04/26New drug · Class 2.4 | 奥雷巴替尼片 · No verified English nameCXHL2300435 | Guangzhou Shun Jian Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/04/26New drug · Class 2.2; 2.4 | 盐酸伊立替康脂质体注射液 · No verified English nameCXHL2300434 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/04/25Import · Class 1 | Epcoritamab注射用浓溶液 · No verified English nameJXSL2300079 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2023/04/25Import · Class 1 | GSK3858279 注射液 · No verified English nameJXSL2300078 | GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Company Limited |
| 2023/04/25Import · Class 1 | GSK3858279 注射液 · No verified English nameJXSL2300077 | GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Company Limited |
| 2023/04/25Import · Class 1 | ARV-471(PF-07850327)片 · No verified English nameJXHL2300095 | Pfizer Inc; Pfizer Investment CO. Ltd. |
| 2023/04/25Import · Class 1 | 注射用Nacubactam · No verified English nameJXHL2300094 | Meiji Seika Pharma Co. Ltd.; Shanghai Fosun Pharmaceutical Industrial Development Company Limited |
| 2023/04/25Import · Class 1 | Vamorolone口服混悬液 · No verified English nameJXHL2300093 | Santhera Pharmaceuticals (Switzerland) Ltd; Sperogenix (Shanghai)Med Tech Co. Ltd. |
| 2023/04/25Generic · Class 3 | Aztreonam For InjectionCYHS2301158 | Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized |
| 2023/04/25Generic · Class 3 | Acetylcysteine InjectionCYHS2301154 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2023/04/25Generic · Class 3 | Famotidine InjectionCYHS2301153 | Nanjing Feng Kai Si Drug Research and Development Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2023/04/25Generic · Class 3 | Methocarbamol InjectionCYHS2301150 | Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized |
| 2023/04/25Generic · Class 3 | 利多卡因丙胺卡因气雾剂 · No verified English nameCYHL2300063 | Ze Zheng (Shanghai) Bio Technology Co., Ltd. romanized |
| 2023/04/25New drug · Class 2.1 | 重组人胰岛素肠溶胶囊 · No verified English nameCXSS2300021 | Hefei Tian Hui Bio Technology Co., Ltd. romanized |
103 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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