YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 529 drug applications between 10 October 2024 and 16 October 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 158, covering 114 drug names.
2024/10/10 – 2024/10/16
- New acceptances this week
- 529
- Drugs with new generic filings (by drug name, de-duplicated)
- 114
- Accepted this week, now under review
- 3
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
529filings, 158 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 225 |
| Generic | 158 |
| New drug | 89 |
| Import | 31 |
| Import re-registration | 14 |
| Unspecified | 12 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 376 |
| TCM | 86 |
| Therapeutic biologic | 62 |
| Biologic | 3 |
| Prophylactic biologic | 2 |
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
114 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Fusidic Acid Cream | 6 | 3 | 15 |
| 2 | Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution | 3 | 3 | 8 |
| 3 | Vonoprazan Fumarate Tablets | 3 | 2 | 60 |
| 4 | Hydrocortisone Sodium Succinate for Injection | 3 | 2 | 16 |
| 5 | Bupivacaine Hydrochloride Injection | 3 | 1 | 4 |
| 6 | Fudosteine oral solution | 3 | 1 | 7 |
| 7 | Dasatinib Tablets | 3 | 1 | 4 |
| 8 | Bromhexine Hydrochloride Injection | 2 | 2 | 8 |
| 9 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 10 | 维生素B6注射液 · No verified English name | 2 | 2 | 10 |
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
325 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guizhou Ke Lun Pharma Co., Ltd. romanized | 9 | 3 | 1 |
| 2 | Janssen-Cilag International NV | 7 | 5 | 0 |
| 3 | Bristol-Myers Squibb Pharma EEIG | 7 | 3 | 0 |
| 4 | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 7 | 1 | 0 |
| 5 | Bard Pharmaceuticals Limited | 6 | 6 | 0 |
| 6 | Jiangsu Shen Hua Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | AstraZeneca AB | 5 | 4 | 0 |
| 8 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 0 |
| 9 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 5 | 2 | 0 |
| 10 | Shanxi Hua Kang Pharma Co., Ltd. romanized | 4 | 4 | 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
169 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/10/16Generic · Class 3 | Alendronate Sodium Oral SolutionCYHS2403492 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2024/10/16Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2403488 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2024/10/16Generic · Class 3 | Mesalazine Gastro-Resistant Prolonged-Release GranulesCYHS2403486 | Beijing Foyou Pharma CO.,LTD |
| 2024/10/16Generic · Class 3 | Mesalazine Gastro-Resistant Prolonged-Release GranulesCYHS2403485 | Beijing Foyou Pharma CO.,LTD |
| 2024/10/16Generic · Class 3 | Bromhexine Hydrochloride InjectionCYHS2403484 | Yi Ling Wan Zhou International Pharmaceutical Co., Ltd. romanized; Jewim Pharmaceutical (Shandong) Co., Ltd. |
| 2024/10/16Generic · Class 3 | Hydrocortisone Sodium Succinate for InjectionCYHS2403482 | Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2024/10/16Generic · Class 3 | 利多卡因丙胺卡因气雾剂 · No verified English nameCYHL2400201 | Jiangxi Hui Ren Pharma Co., Ltd. romanized |
| 2024/10/16New drug · Class 3.3 | 冻干人用狂犬病疫苗(人二倍体细胞) · No verified English nameCXSS2400112 | Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized |
| 2024/10/16New drug · Class 1 | IBI3005 · No verified English nameCXSL2400699 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2024/10/16New drug · Class 1 | RGB-5088胰岛细胞注射液 · No verified English nameCXSL2400698 | Hangzhou Rui Pu Chen Chuang Technology Co., Ltd. romanized |
| 2024/10/16New drug · Class 1 | CM559注射液 · No verified English nameCXSL2400697 | Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
| 2024/10/16New drug · Class 1 | SHR-1819注射液 · No verified English nameCXSL2400696 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/10/16New drug · Class 1 | HDM1005注射液 · No verified English nameCXHL2401093 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2024/10/16New drug · Class 1 | HDM1005注射液 · No verified English nameCXHL2401092 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2024/10/16New drug · Class 2.2 | SXF-100 · No verified English nameCXHL2401091 | Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized |
| 2024/10/16New drug · Class 2.3 | 奥美沙坦酯左氨氯地平片 · No verified English nameCXHL2401090 | Beijing Foyou Pharma CO.,LTD |
| 2024/10/16New drug · Class 1 | PZH2109胶囊 · No verified English nameCXHL2401089 | Zhang Zhou Pian Zai Huang Pharma Co., Ltd. romanized |
| 2024/10/16New drug · Class 1 | PZH2109胶囊 · No verified English nameCXHL2401088 | Zhang Zhou Pian Zai Huang Pharma Co., Ltd. romanized |
| 2024/10/16New drug · Class 1 | PZH2109胶囊 · No verified English nameCXHL2401087 | Zhang Zhou Pian Zai Huang Pharma Co., Ltd. romanized |
| 2024/10/16New drug · Class 1 | HJ787软膏 · No verified English nameCXHL2401086 | Chengdu Hua Jian Wei Lai Technology Co., Ltd. romanized |
| 2024/10/16New drug · Class 1 | HJ787软膏 · No verified English nameCXHL2401085 | Chengdu Hua Jian Wei Lai Technology Co., Ltd. romanized |
| 2024/10/16New drug · Class 1 | TollB-001片 · No verified English nameCXHL2401084 | Beijing Tuo Ling Bo Tai Bio Technology Co., Ltd. romanized |
| 2024/10/16New drug · Class 1 | TollB-001片 · No verified English nameCXHL2401083 | Beijing Tuo Ling Bo Tai Bio Technology Co., Ltd. romanized |
| 2024/10/16New drug · Class 1 | PD-DP-008凝胶 · No verified English nameCXHL2401082 | Chengdu Pei De Biopharmaceuticals Co., Ltd. romanized |
| 2024/10/15Import · Class 1 | Aficamten片 · No verified English nameJXHS2400085 | Cytokinetics Incorporated; Patheon Inc.; Sanofi (China) Investment Co. Ltd. |
| 2024/10/15Import · Class 1 | Bepirovirsen 注射液 · No verified English nameJXHL2400246 | GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Company Limited |
| 2024/10/15Import · Class 1 | Daplusiran/Tomligisiran 注射液 · No verified English nameJXHL2400245 | GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Company Limited |
| 2024/10/15Generic · Class 3 | Hydrocortisone Sodium Succinate for InjectionCYHS2403475 | Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized; Chongqing Lai Mei Pharma Co., Ltd. romanized |
| 2024/10/15Generic · Class 3 | Hydrocortisone Sodium Succinate for InjectionCYHS2403474 | Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized; Chongqing Lai Mei Pharma Co., Ltd. romanized |
| 2024/10/15Generic · Class 3 | 聚乙二醇3350散 · No verified English nameCYHS2403471 | Ma Ying Long Pharma Group Co., Ltd. romanized |
139 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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