YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 263 drug applications between 28 May 2024 and 3 June 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 73, covering 55 drug names.
2024/05/28 – 2024/06/03
- New acceptances this week
- 263
- Drugs with new generic filings (by drug name, de-duplicated)
- 55
- Accepted this week, now under review
- 1
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
263filings, 73 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 122 |
| Generic | 73 |
| New drug | 47 |
| Import | 18 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 182 |
| Therapeutic biologic | 40 |
| TCM | 37 |
| Prophylactic biologic | 3 |
| 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
55 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Lactulose Oral Solution | 7 | 3 | 34 |
| 2 | 二甲硅油乳剂 · No verified English name | 3 | 1 | 14 |
| 3 | 阿普米司特片 · No verified English name | 3 | 1 | 3 |
| 4 | Bumetanide Injection | 2 | 1 | 13 |
| 5 | Minocycline Hydrochloride Capsules | 2 | 1 | 19 |
| 6 | Thioctic Acid Tablets | 2 | 1 | 4 |
| 7 | Ioversol Injection | 2 | 1 | 9 |
| 8 | Sitagliptin Phosphate Tablets | 2 | 1 | 2 |
| 9 | Vitamin K1 Injection | 2 | 1 | 6 |
| 10 | Roxadustat Capsules | 2 | 1 | 17 |
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
164 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Henan Hua Feng Pharmaceutical Co., Ltd. romanized | 9 | 9 | 0 |
| 2 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 8 | 4 | 0 |
| 3 | CHEPLAPHARM Registration GmbH | 7 | 2 | 0 |
| 4 | Eli Lilly and Company | 6 | 1 | 0 |
| 5 | Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized | 6 | 1 | 0 |
| 6 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 5 | 2 | 0 |
| 7 | Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 5 | 1 | 0 |
| 8 | Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized | 4 | 4 | 4 |
| 9 | Shandong Bo An Bio Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Novartis Europharm Limited | 3 | 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
82 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/06/03Import · Class 1 | 伊那利塞片 · No verified English nameJXHS2400038 | Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche AG; Roche (China) Holding Ltd. |
| 2024/06/03Import · Class 1 | 伊那利塞片 · No verified English nameJXHS2400037 | Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche AG; Roche (China) Holding Ltd. |
| 2024/06/01Import · Class 3.1 | 呼吸道合胞病毒疫苗 · No verified English nameJXSL2400107 | Pfizer Inc.; Pfizer Investment CO Ltd. |
| 2024/06/01Import · Class 2.2; 2.4 | 克拉屈滨胶囊 · No verified English nameJXHL2400125 | Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd |
| 2024/06/01Import · Class 2.2; 2.4 | 克拉屈滨胶囊 · No verified English nameJXHL2400124 | Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd |
| 2024/06/01Generic · Class 3 | Epalrestat TabletsCYHS2401651 | Zhong Mei Hua Shi Tong Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized; Hubei Hua Shi Tong Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/06/01Generic · Class 3 | Potassium Chloride GranulesCYHS2401648 | Shandong Pu Rui Man Pharma Co., Ltd. romanized |
| 2024/06/01Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2401646 | Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized |
| 2024/06/01Generic · Class 3 | Bumetanide InjectionCYHS2401641 | Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2024/06/01Generic · Class 3 | Bumetanide InjectionCYHS2401640 | Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2024/06/01New drug · Class 1 | CS060380片 · No verified English nameCXHL2400553 | Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/06/01New drug · Class 1 | CS060380片 · No verified English nameCXHL2400552 | Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/06/01New drug · Class 1 | CS060380片 · No verified English nameCXHL2400551 | Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/05/31Import · Class 2.2 | Dostarlimab注射液 · No verified English nameJXSL2400106 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd. |
| 2024/05/31Import · Class 1 | VAY736注射液 · No verified English nameJXSL2400105 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2024/05/31Generic · Class 3 | Amisulpride Oral SolutionCYHS2401638 | Changzhou Si Yao Pharmaceutical Co., Ltd. romanized |
| 2024/05/31Generic · Class 3 | 氯化钙注射液 · No verified English nameCYHS2401634 | Hebei Qian Kang Pharmaceuticals Technology Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd. |
| 2024/05/31Generic · Class 3 | Isoniazid InjectionCYHS2401633 | Ta He Shi Hui Chuang Pharmaceuticals Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized |
| 2024/05/31Generic · Class 3 | Vitamin K1 InjectionCYHS2401632 | Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized |
| 2024/05/31Generic · Class 3 | Vitamin K1 InjectionCYHS2401631 | Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized |
| 2024/05/31New drug · Class 1 | 夫那奇珠单抗注射液 · No verified English nameCXSL2400363 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2024/05/31New drug · Class 1 | 夫那奇珠单抗注射液 · No verified English nameCXSL2400362 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2024/05/31New drug · Class 1 | 夫那奇珠单抗注射液 · No verified English nameCXSL2400361 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2024/05/31New drug · Class 1 | 注射用LNF2007双特异性抗体 · No verified English nameCXSL2400360 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2024/05/31New drug · Class 1 | SHR-2106注射液 · No verified English nameCXSL2400359 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/05/31New drug · Class 1 | 注射用HS-20093 · No verified English nameCXSL2400358 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2024/05/31New drug · Class 1 | 注射用HS-20093 · No verified English nameCXSL2400357 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2024/05/31New drug · Class 1 | HS-20117注射液 · No verified English nameCXSL2400356 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2024/05/31New drug · Class 1 | XMVA09注射液 · No verified English nameCXSL2400355 | Hefei Xing Mou Bio Technology Co., Ltd. romanized |
| 2024/05/31New drug · Class 1 | BGB-45035片 · No verified English nameCXHL2400550 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
52 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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