YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 259 drug applications between 25 May 2024 and 31 May 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 70, covering 54 drug names.
2024/05/25 – 2024/05/31
- New acceptances this week
- 259
- Drugs with new generic filings (by drug name, de-duplicated)
- 54
- 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
259filings, 70 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 118 |
| Generic | 70 |
| New drug | 50 |
| Import | 11 |
| Import re-registration | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 172 |
| TCM | 43 |
| Therapeutic biologic | 41 |
| Prophylactic biologic | 2 |
| 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
54 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 | 阿普米司特片 · No verified English name | 3 | 1 | 3 |
| 3 | Minocycline Hydrochloride Capsules | 2 | 1 | 19 |
| 4 | Esmolol Hydrochloride and Sodium Chloride Injection | 2 | 1 | 0 |
| 5 | Thioctic Acid Tablets | 2 | 1 | 4 |
| 6 | Ioversol Injection | 2 | 1 | 9 |
| 7 | Sitagliptin Phosphate Tablets | 2 | 1 | 2 |
| 8 | Vitamin K1 Injection | 2 | 1 | 6 |
| 9 | Roxadustat Capsules | 2 | 1 | 17 |
| 10 | Azilsartan Medoxomil Potassium Tablets | 2 | 1 | 35 |
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
156 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 | Fresenius Kabi Austria GmbH | 4 | 1 | 0 |
| 9 | Shandong Bo An Bio Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Jilin Sheng Hua Qiao Pharma Group Co., Ltd. romanized | 3 | 3 | 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
80 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2024/05/31New drug · Class 2.2 | BCM878口崩片 · No verified English nameCXHL2400549 | Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized |
| 2024/05/31New drug · Class 1 | BGB-45035片 · No verified English nameCXHL2400548 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2024/05/31New drug · Class 1 | ABP2111Na片 · No verified English nameCXHL2400547 | Shanghai Ai Bo Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/05/31New drug · Class 1 | ABP2111Na片 · No verified English nameCXHL2400546 | Shanghai Ai Bo Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/05/30Generic · Class 3 | Thioctic Acid TabletsCYHS2401626 | Suzhou Fu Shi Lai Pharmaceuticals Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/05/30Generic · Class 3 | Thioctic Acid TabletsCYHS2401625 | Suzhou Fu Shi Lai Pharmaceuticals Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/05/30Generic · Class 3 | Articaine Hydrochloride And Epinephrine InjectionCYHS2401623 | Yang Zhou Zhong Bao Pharma Co., Ltd. romanized |
| 2024/05/30New drug · Class 3.1 | 开心散 · No verified English nameCXZS2400019 | Shandong Run Zhong Pharma Co., Ltd. romanized |
| 2024/05/30New drug · Class 1 | MG-K10人源化单抗注射液 · No verified English nameCXSL2400354 | Shanghai Mai Ji Bio Technology Co., Ltd. romanized |
| 2024/05/30New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2400353 | Zhejiang Quan Sheng Bio Technology Co., Ltd. romanized; Hainan Xin Sheng Quan Gan Xi Bao Drug Co., Ltd. romanized |
| 2024/05/30New drug · Class 1 | 177Lu-LNC1011注射液 · No verified English nameCXHL2400545 | Yan Tai Lan Na Cheng Bio Technology Co., Ltd. romanized |
| 2024/05/29Generic · Class 3 | 利伐沙班颗粒 · No verified English nameCYHS2401606 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2024/05/29Generic · Class 3 | Chlorphenamine Maleate InjectionCYHS2401605 | Bao Li Hua (Nanjing) Pharmaceutical Co., Ltd. romanized |
50 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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