YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 423 drug applications between 10 May 2023 and 16 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 69, covering 50 drug names.
2023/05/10 – 2023/05/16
- New acceptances this week
- 423
- Drugs with new generic filings (by drug name, de-duplicated)
- 50
- 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
423filings, 69 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 252 |
| Generic | 69 |
| New drug | 55 |
| Import | 24 |
| Import re-registration | 13 |
| Unspecified | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 254 |
| TCM | 123 |
| Therapeutic biologic | 46 |
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
50 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 硝普钠氯化钠注射液 · No verified English name | 4 | 1 | 3 |
| 2 | Famotidine Injection | 3 | 3 | 8 |
| 3 | 吸入用七氟烷 · No verified English name | 3 | 1 | 0 |
| 4 | Paroxetine Hydrochloride Enteric-Coated Sustained-Release Tablets | 3 | 1 | 0 |
| 5 | Levofloxacin Oral Solution | 2 | 2 | 1 |
| 6 | Levofloxacin Eye Drops | 2 | 2 | 16 |
| 7 | Carbazochrome Sodium Sulfonate Injection | 2 | 1 | 1 |
| 8 | Ipratropium Bromide Inhalation Solution | 2 | 1 | 2 |
| 9 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 10 | Quetiapine Fumarate Extended-release 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
204 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | An Yang Guang Sheng Heng Pharmaceutical Co., Ltd. romanized | 62 | 50 | 0 |
| 2 | Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized | 15 | 15 | 0 |
| 3 | Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized | 15 | 14 | 0 |
| 4 | Hebei Kai Wei Heng Cheng Pharmaceutical Co., Ltd. romanized | 14 | 10 | 0 |
| 5 | Bard Pharmaceuticals Limited | 7 | 3 | 0 |
| 6 | AbbVie Inc. | 6 | 2 | 0 |
| 7 | Eli Lilly and Company | 6 | 1 | 0 |
| 8 | Changsha Ai Bei Gao Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Bright Future Pharmaceuticals Factory | 5 | 4 | 0 |
| 10 | Hua Bei Pharmaceutical Group Xian Tai Pharma Co., Ltd. romanized | 5 | 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
99 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/05/16Import · Class 2.2 | Glofitamab注射液 · No verified English nameJXSL2300093 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2023/05/16Import · Class 1 | CC-99282胶囊 · No verified English nameJXHL2300117 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2023/05/16Import · Class 2.4 | Infigratinib胶囊 · No verified English nameJXHL2300116 | LianBio Development (HK) Limited; Shanghai LianBio Development Co. Ltd. |
| 2023/05/16Import · Class 2.4 | Infigratinib胶囊 · No verified English nameJXHL2300115 | LianBio Development (HK) Limited; Shanghai LianBio Development Co. Ltd. |
| 2023/05/16Generic · Class 3 | Levofloxacin Oral SolutionCYHS2301322 | Hubei Xin Ze Fei Pharma Co., Ltd. romanized |
| 2023/05/16Generic · Class 3 | Famotidine InjectionCYHS2301317 | Sichuan Pharmaceutical Formulations Co., Ltd. romanized; Chengdu Li Er Pharma Co., Ltd. romanized |
| 2023/05/16Generic · Class 3 | 注射用水溶性维生素 · No verified English nameCYHS2301315 | Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2023/05/16New drug · Class 1.1 | 枳术通便颗粒 · No verified English nameCXZL2300035 | Jian Min Pharma Group Co., Ltd. romanized |
| 2023/05/16New drug · Class 1 | 苏帕鲁肽注射液 · No verified English nameCXSL2300342 | Shanghai Yin Nuo Biopharmaceuticals Gong Cheng Co., Ltd. romanized |
| 2023/05/16New drug · Class 1 | 苏帕鲁肽注射液 · No verified English nameCXSL2300341 | Shanghai Yin Nuo Biopharmaceuticals Gong Cheng Co., Ltd. romanized |
| 2023/05/16New drug · Class 1 | 苏帕鲁肽注射液 · No verified English nameCXSL2300340 | Shanghai Yin Nuo Biopharmaceuticals Gong Cheng Co., Ltd. romanized |
| 2023/05/16New drug · Class 1 | 苏帕鲁肽注射液 · No verified English nameCXSL2300339 | Shanghai Yin Nuo Biopharmaceuticals Gong Cheng Co., Ltd. romanized |
| 2023/05/16New drug · Class 1 | 注射用LBL-034 · No verified English nameCXSL2300338 | Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized |
| 2023/05/16New drug · Class 1 | AZD5863 · No verified English nameCXSL2300337 | A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized |
| 2023/05/16New drug · Class 1 | 甲磺酸帕拉德福韦片 · No verified English nameCXHS2300049 | Xian Ge Lan Xin Tong Pharmaceutical Co., Ltd. romanized |
| 2023/05/16New drug · Class 1 | TQB3912片 · No verified English nameCXHL2300527 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/05/16New drug · Class 1 | TQB3912片 · No verified English nameCXHL2300526 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/05/16New drug · Class 2.3 | TAF-001乳膏 · No verified English nameCXHL2300525 | Shanghai Ze De Man Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/16New drug · Class 1 | SPH7050颗粒 · No verified English nameCXHL2300524 | Shanghai Pharmaceuticals Group Co., Ltd. romanized |
| 2023/05/16New drug · Class 1 | SPH7050颗粒 · No verified English nameCXHL2300523 | Shanghai Pharmaceuticals Group Co., Ltd. romanized |
| 2023/05/16New drug · Class 1 | YY201片 · No verified English nameCXHL2300522 | Shanghai Yu Yao Bio Technology Co., Ltd. romanized |
| 2023/05/16New drug · Class 1 | YY201片 · No verified English nameCXHL2300521 | Shanghai Yu Yao Bio Technology Co., Ltd. romanized |
| 2023/05/16New drug · Class 1 | MH004乳膏 · No verified English nameCXHL2300520 | Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2023/05/16New drug · Class 1 | GT929胶囊 · No verified English nameCXHL2300519 | Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/05/16New drug · Class 1 | GT929胶囊 · No verified English nameCXHL2300518 | Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/05/16New drug · Class 1 | GT929胶囊 · No verified English nameCXHL2300517 | Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/05/15Generic · Class 3 | Phosribbon combination granulesCYHS2301310 | Jia Shi (Hunan) Pharmaceuticals Technology Co., Ltd. romanized; Hunan Tian Ji Cao Tang Pharmaceutical Co., Ltd. romanized |
| 2023/05/13Generic · Class 3 | Propranolol Hydrochloride InjectionCYHS2301309 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2023/05/13Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2301308 | Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2023/05/13Generic · Class 3 | Tirofiban Hydrochloride And Sodium Chloride InjectionCYHS2301307 | Henan Run Hong Pharmaceutical Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
69 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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