YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 428 drug applications between 22 April 2023 and 28 April 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 85, covering 56 drug names.
2023/04/22 – 2023/04/28
- New acceptances this week
- 428
- Drugs with new generic filings (by drug name, de-duplicated)
- 56
- 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
428filings, 85 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 226 |
| Generic | 85 |
| New drug | 66 |
| Import | 29 |
| Import re-registration | 13 |
| Unspecified | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 289 |
| TCM | 78 |
| Therapeutic biologic | 52 |
| Biologic | 4 |
| Prophylactic biologic | 4 |
| In vitro diagnostic reagent | 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
56 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 | Duloxetine Hydrochloride Enteric Capsules | 3 | 1 | 4 |
| 4 | Sitagliptin and Metformin Hydrochloride Extended-release Tablets | 3 | 1 | 12 |
| 5 | 硫酸特布他林雾化吸入用溶液 · No verified English name | 2 | 2 | 1 |
| 6 | Sugammadex Sodium Injection | 2 | 2 | 6 |
| 7 | Procaterol Hydrochloride Solution for Inhalation | 2 | 1 | 2 |
| 8 | 复方醋酸钠林格注射液 · No verified English name | 2 | 1 | 2 |
| 9 | 异氟烷 · No verified English name | 2 | 1 | 0 |
| 10 | Topiroxostat Tablets | 2 | 1 | 0 |
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 | 23 | 18 | 0 |
| 2 | Anhui Xian Gui Pharmaceuticals Technology Co., Ltd. romanized | 14 | 14 | 0 |
| 3 | Sichuan He Li Xin Jian Pharma Co., Ltd. romanized | 14 | 10 | 0 |
| 4 | Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized | 10 | 9 | 0 |
| 5 | Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized | 10 | 7 | 0 |
| 6 | Zhejiang Guo Jing Pharma Co., Ltd. romanized | 9 | 2 | 0 |
| 7 | Tong Yong Dian Qi Pharma (Shanghai) Co., Ltd. romanized | 8 | 1 | 8 |
| 8 | Guo Xin (Heilongjiang) Pharmaceutical Co., Ltd. romanized | 7 | 7 | 0 |
| 9 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 6 | 3 | 0 |
| 10 | Roche Pharma (Schweiz) AG | 6 | 2 | 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
122 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/04/28Import · Class 2.2 | TV-44749 · No verified English nameJXHL2300099 | Teva Branded Pharmaceutical Products R&D Inc. |
| 2023/04/28Generic · Class 3 | 氢化可的松缓释片 · No verified English nameCYHL2300068 | Jin Yao Pharma Co., Ltd. romanized |
| 2023/04/28Generic · Class 3 | 氢化可的松缓释片 · No verified English nameCYHL2300067 | Jin Yao Pharma Co., Ltd. romanized |
| 2023/04/28New drug · Class 3.1 | 芍药甘草颗粒 · No verified English nameCXZS2300010 | Shen Wei Pharma Group Co., Ltd. romanized |
| 2023/04/28New drug · Class 1 | SNP201注射液 · No verified English nameCXSL2300297 | Sai Shen (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/04/28New drug · Class 2.2 | 注射用重组改构人肿瘤坏死因子 · No verified English nameCXSL2300296 | Shanghai Wei Ke Biopharmaceutical Co., Ltd. romanized |
| 2023/04/28New drug · Class 1 | JY016注射液 · No verified English nameCXSL2300295 | Beijing Dong Fang Bai Tai Bio Technology Co., Ltd. romanized; Beijing Jing Yi Tai Xiang Technology Development Co., Ltd. romanized |
| 2023/04/28New drug · Class 1 | VGM-R02b · No verified English nameCXSL2300294 | Shanghai Tian Ze Yun Tai Biopharmaceuticals Co., Ltd. romanized |
| 2023/04/28New drug · Class 1 | QB0208-1胶囊 · No verified English nameCXHL2300445 | Beijing Qing Bo Hui Neng Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/04/28New drug · Class 1 | QB0208-1胶囊 · No verified English nameCXHL2300444 | Beijing Qing Bo Hui Neng Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/04/28New drug · Class 2.3 | HY22017胶囊 · No verified English nameCXHL2300443 | Changchun Hai Yue Pharma Co., Ltd. romanized |
| 2023/04/28New drug · Class 1 | DZ2002 · No verified English nameCXHL2300442 | Ningbo Zi Yuan Pharma Co., Ltd. romanized |
| 2023/04/28New drug · Class 1 | DZ2002 · No verified English nameCXHL2300441 | Ningbo Zi Yuan Pharma Co., Ltd. romanized |
| 2023/04/27Import · Class 1 | 注射用SAR444200 · No verified English nameJXSL2300081 | Sanofi-Aventis Recherche & Développement; Sanofi(China)Investment Co. Ltd. |
| 2023/04/27Generic · Class 3 | Minodronic acid TabletsCYHS2301180 | Anhui Bo Nuo Mei Ke Biopharmaceuticals Co., Ltd. romanized; Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized |
| 2023/04/27Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2301179 | Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Guo Yao Group Guo Rui Pharma Co., Ltd. romanized |
| 2023/04/27Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2301178 | Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Guo Yao Group Guo Rui Pharma Co., Ltd. romanized |
| 2023/04/27Generic · Class 3 | Topiroxostat TabletsCYHL2300066 | Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/04/27Generic · Class 3 | Topiroxostat TabletsCYHL2300065 | Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/04/27New drug · Class 2.1 | 双黄连吸入溶液 · No verified English nameCXZL2300031 | Shen Wei Pharma Group Co., Ltd. romanized; Beijing Ying Ke Rui Innovation Pharmaceuticals Co., Ltd. romanized |
| 2023/04/27New drug · Class 3.3 | 注射用曲妥珠单抗 · No verified English nameCXSS2300027 | Qilu Pharmaceutical Co., Ltd. |
| 2023/04/27New drug · Class 1 | 夫那奇珠单抗注射液 · No verified English nameCXSS2300026 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2023/04/27New drug · Class 1.4 | 二价肠道病毒灭活疫苗(Vero细胞) · No verified English nameCXSL2300293 | Beijing Ke Xing Bio Zhi Pin Co., Ltd. romanized |
| 2023/04/27New drug · Class 1.4 | 二价肠道病毒灭活疫苗(Vero细胞) · No verified English nameCXSL2300292 | Beijing Ke Xing Bio Zhi Pin Co., Ltd. romanized |
| 2023/04/27New drug · Class 1.4 | 二价肠道病毒灭活疫苗(Vero细胞) · No verified English nameCXSL2300291 | Beijing Ke Xing Bio Zhi Pin Co., Ltd. romanized |
| 2023/04/27New drug · Class 1 | GT201注射液 · No verified English nameCXSL2300290 | Suzhou Sha Li Bio Technology Co., Ltd. romanized |
| 2023/04/27New drug · Class 1 | GB002重组多肽吸入溶液 · No verified English nameCXSL2300289 | Nanning Ji Rui Biopharmaceuticals Co., Ltd. romanized; Zhejiang Ying Kang Biopharmaceuticals Co., Ltd. romanized |
| 2023/04/27New drug · Class 1 | 注射用SKB264 · No verified English nameCXSL2300288 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2023/04/27New drug · Class 1 | FWD1802片 · No verified English nameCXHL2300440 | Shenzhen Fu Wo Pharma Co., Ltd. romanized |
| 2023/04/27New drug · Class 1 | FWD1802片 · No verified English nameCXHL2300439 | Shenzhen Fu Wo Pharma Co., Ltd. romanized |
92 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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