YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 308 drug applications between 16 May 2024 and 22 May 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 75, covering 56 drug names.
2024/05/16 – 2024/05/22
- New acceptances this week
- 308
- Drugs with new generic filings (by drug name, de-duplicated)
- 56
- 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
308filings, 75 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 149 |
| Generic | 75 |
| New drug | 52 |
| Import | 16 |
| Import re-registration | 13 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 203 |
| TCM | 56 |
| Therapeutic biologic | 44 |
| 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
56 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 | 盐酸纳美芬注射液 · No verified English name | 2 | 2 | 1 |
| 4 | Glyburide and Metformin Hydrochloride Tablets | 2 | 1 | 0 |
| 5 | 利伐沙班干混悬剂 · No verified English name | 2 | 1 | 2 |
| 6 | Linagliptin and Metformin Hydrochloride Extended Release Tablets | 2 | 1 | 4 |
| 7 | Montelukast Sodium Orally Disintegrating Tablets | 2 | 1 | 0 |
| 8 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 9 | Levetiracetam extended-release tablets | 2 | 1 | 0 |
| 10 | Paliperidone Extend-release Tablets | 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
193 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 | Bracco Imaging S.P.A. | 6 | 1 | 0 |
| 4 | HUNAN WARRANT PHARMACEUTICAL CO.,LTD | 5 | 3 | 3 |
| 5 | Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized | 5 | 1 | 0 |
| 6 | Shanghai Wan Shi Cheng Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Anhui Zhong Chen Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Jilin Heng Xing Technology Pharmaceutical Co., Ltd. romanized | 4 | 3 | 0 |
| 9 | Fresenius Kabi AB | 4 | 1 | 0 |
| 10 | Novartis Europharm Limited | 4 | 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
102 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2024/05/22Generic · Class 3 | 洛索洛芬钠细粒剂 · No verified English nameCYHS2401527 | Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/05/22Generic · Class 3 | Proparacaine Hydrochloride Eye DropsCYHS2401525 | Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized |
| 2024/05/22Generic · Class 3 | 平衡盐冲洗液 · No verified English nameCYHS2401523 | Xian Jing Xi Shuang He Pharma Co., Ltd. romanized |
| 2024/05/22Generic · Class 3 | 平衡盐冲洗液 · No verified English nameCYHS2401522 | Xian Jing Xi Shuang He Pharma Co., Ltd. romanized |
| 2024/05/22Generic · Class 3 | Mannitol-S InjectionCYHL2400099 | Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized |
| 2024/05/22New drug · Class 1 | IBI354 · No verified English nameCXSL2400335 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2024/05/22New drug · Class 1 | SHR-1819注射液 · No verified English nameCXSL2400334 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/05/22New drug · Class 2.2 | 水合氯醛口服溶液 · No verified English nameCXHS2400045 | Chengdu Ya Zhong Biopharmaceutical Co., Ltd. romanized; Sichuan Guang Da Pharmaceutical Co., Ltd. romanized |
| 2024/05/22New drug · Class 1 | 枸橼酸格来雷塞片 · No verified English nameCXHS2400044 | Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized |
| 2024/05/22New drug · Class 1 | HLX208片 · No verified English nameCXHL2400518 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized |
| 2024/05/22New drug · Class 1 | 注射用WE011 · No verified English nameCXHL2400517 | Shanghai Bao Long Pharma Co., Ltd. romanized |
| 2024/05/22New drug · Class 2.3 | SMF-215 · No verified English nameCXHL2400516 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2024/05/21Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2401521 | Hainan Quan Xing Pharmaceutical Co., Ltd. romanized |
| 2024/05/21Generic · Class 3 | Betamethasone Sodium Phosphate InjectionCYHS2401520 | Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized |
| 2024/05/21Generic · Class 3 | Levetiracetam extended-release tabletsCYHS2401519 | Fo Shan De Rui Ke Pharmaceutical Co., Ltd. romanized |
| 2024/05/21Generic · Class 3 | Levetiracetam extended-release tabletsCYHS2401517 | Fo Shan De Rui Ke Pharmaceutical Co., Ltd. romanized |
72 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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