YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 329 drug applications between 17 May 2024 and 23 May 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 83, covering 62 drug names.
2024/05/17 – 2024/05/23
- New acceptances this week
- 329
- Drugs with new generic filings (by drug name, de-duplicated)
- 62
- Accepted this week, now under review
- 2
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
329filings, 83 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 151 |
| Generic | 83 |
| New drug | 57 |
| Import re-registration | 19 |
| Import | 14 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 223 |
| TCM | 58 |
| Therapeutic biologic | 43 |
| Prophylactic biologic | 3 |
| In vitro diagnostic reagent | 1 |
| Biologic | 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
62 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Tadalafil Tablets | 3 | 1 | 23 |
| 2 | Diprophylline Injection | 2 | 2 | 7 |
| 3 | Levofloxacin Eye Drops | 2 | 2 | 16 |
| 4 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 2 | 2 | 23 |
| 5 | 盐酸纳美芬注射液 · No verified English name | 2 | 2 | 1 |
| 6 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 7 | Glyburide and Metformin Hydrochloride Tablets | 2 | 1 | 0 |
| 8 | 利伐沙班干混悬剂 · No verified English name | 2 | 1 | 2 |
| 9 | Linagliptin and Metformin Hydrochloride Extended Release Tablets | 2 | 1 | 4 |
| 10 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
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
207 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 8 | 2 | 0 |
| 2 | Sanofi Winthrop Industrie | 6 | 2 | 0 |
| 3 | Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized | 6 | 2 | 0 |
| 4 | Bracco Imaging S.P.A. | 6 | 1 | 0 |
| 5 | HUNAN WARRANT PHARMACEUTICAL CO.,LTD | 5 | 3 | 3 |
| 6 | Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Shanghai Wan Shi Cheng Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Anhui Zhong Chen Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Jilin Heng Xing Technology Pharmaceutical Co., Ltd. romanized | 4 | 3 | 0 |
| 10 | Boehringer Ingelheim Pharma GmbH & Co. KG | 4 | 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
108 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/05/23Generic · Class 3 | Bromhexine Hydrochloride InjectionCYHS2401551 | Heilongjiang Ao Li Da Nai De Pharmaceutical Co., Ltd. romanized |
| 2024/05/23Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2401549 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Zhong Fu Pharma Co., Ltd. romanized |
| 2024/05/23Generic · Class 3 | Indobufen TabletsCYHS2401547 | Hebei Long Hai Pharma Co., Ltd. romanized |
| 2024/05/23New drug · Class 1 | Obexelimab注射液 · No verified English nameCXSL2400339 | Shanghai Ze Na Shi Bio Technology Co., Ltd. romanized |
| 2024/05/23New drug · Class 1 | DCTY1102注射液 · No verified English nameCXSL2400338 | Beijing Ding Cheng Tai Yuan Bio Technology Co., Ltd. romanized |
| 2024/05/23New drug · Class 1 | SHR-7787注射液 · No verified English nameCXSL2400337 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/05/23New drug · Class 1 | SHR-7787注射液 · No verified English nameCXSL2400336 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/05/23New drug · Class 1 | 复迈替尼片 · No verified English nameCXHS2400047 | Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized |
| 2024/05/23New drug · Class 1 | 复迈替尼片 · No verified English nameCXHS2400046 | Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized |
| 2024/05/23New drug · Class 2.2; 2.4 | HR19024注射液 · No verified English nameCXHL2400525 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/05/23New drug · Class 1 | ENN0403胶囊 · No verified English nameCXHL2400524 | Yi Nuo (Zhejiang) Pharma Co., Ltd. romanized; Shanghai Yi Nuo Pharma Co., Ltd. romanized |
| 2024/05/23New drug · Class 1 | DG01片 · No verified English nameCXHL2400523 | Suzhou De Gen Biopharmaceuticals Co., Ltd. romanized |
| 2024/05/23New drug · Class 1 | DG01片 · No verified English nameCXHL2400522 | Suzhou De Gen Biopharmaceuticals Co., Ltd. romanized |
| 2024/05/23New drug · Class 1 | BG-68501片 · No verified English nameCXHL2400521 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2024/05/23New drug · Class 1 | BG-68501片 · No verified English nameCXHL2400520 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2024/05/23New drug · Class 1 | YZG-331片 · No verified English nameCXHL2400519 | Zhongguo Yi Xue Ke College Drug Research Institute romanized |
| 2024/05/22Import · Class 2.2 | 艾沙妥昔单抗注射液 · No verified English nameJXSS2400044 | Sanofi Winthrop Industrie; Sanofi-Aventis Deutschland GmbH |
| 2024/05/22Import · Class 2.2 | 艾沙妥昔单抗注射液 · No verified English nameJXSS2400043 | Sanofi Winthrop Industrie; Sanofi-Aventis Deutschland GmbH |
| 2024/05/22Import · Class 1 | Englumafusp alfa注射液 · No verified English nameJXSL2400098 | F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd. |
| 2024/05/22Import · Class 1 | ABBV-382注射液 · No verified English nameJXSL2400097 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2024/05/22Import · Class 1 | VSA001注射液 · No verified English nameJXHL2400116 | Arrowhead Pharmaceuticals Inc.; Sanofi (China) Investment Co. Ltd. |
| 2024/05/22Generic · Class 3 | 盐酸纳美芬注射液 · No verified English nameCYHS2401539 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Hainan Ai Ke Pharmaceutical Co., Ltd. romanized |
| 2024/05/22Generic · Class 3 | Famotidine InjectionCYHS2401538 | Beijing Ge Lin Yi Rui Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Minsheng Pharmaceutical Co., Ltd |
| 2024/05/22Generic · Class 3 | Famotidine InjectionCYHS2401537 | Beijing Ge Lin Yi Rui Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Minsheng Pharmaceutical Co., Ltd |
| 2024/05/22Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2401536 | Guangdong Nan Guo Pharma Co., Ltd. romanized |
| 2024/05/22Generic · Class 3 | Cimetidine InjectionCYHS2401535 | Nanjing Si Tai Er Pharmaceuticals Technology Co., Ltd. romanized; Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized |
| 2024/05/22Generic · Class 3 | Isoprenaline Hydrochloride InjectionCYHS2401534 | HUNAN WARRANT PHARMACEUTICAL CO.,LTD |
| 2024/05/22Generic · Class 3 | Isoprenaline Hydrochloride InjectionCYHS2401533 | HUNAN WARRANT PHARMACEUTICAL CO.,LTD |
| 2024/05/22Generic · Class 3 | 二硫化硒洗剂 · No verified English nameCYHS2401529 | Anhui Pioneer Pharmaceutical Co., Ltd |
| 2024/05/22Generic · Class 3 | Diprophylline InjectionCYHS2401528 | Guangzhou He He Pharmaceuticals Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized |
78 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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