YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 359 drug applications between 12 May 2024 and 18 May 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 89, covering 65 drug names.
2024/05/12 – 2024/05/18
- New acceptances this week
- 359
- Drugs with new generic filings (by drug name, de-duplicated)
- 65
- Accepted this week, now under review
- 5
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
359filings, 89 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 146 |
| Generic | 89 |
| New drug | 81 |
| Import | 20 |
| Import re-registration | 15 |
| Unspecified | 5 |
| Drug-device combination product | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 249 |
| Therapeutic biologic | 59 |
| TCM | 40 |
| Prophylactic biologic | 8 |
| Drug-device combination | 3 |
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
65 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 3 | 2 | 60 |
| 2 | Sacubitril Valsartan Sodium Tablets | 3 | 2 | 70 |
| 3 | Tadalafil Tablets | 3 | 1 | 23 |
| 4 | 复方聚乙二醇(3350)电解质散 · No verified English name | 2 | 2 | 3 |
| 5 | Famotidine Injection | 2 | 2 | 8 |
| 6 | 洛索洛芬钠凝胶贴膏 · No verified English name | 2 | 2 | 9 |
| 7 | Phenylephrine Hydrochloride Injection | 2 | 2 | 5 |
| 8 | Glyburide and Metformin Hydrochloride Tablets | 2 | 1 | 0 |
| 9 | Tacrolimus Sustained-release Capsules | 2 | 1 | 6 |
| 10 | 利伐沙班干混悬剂 · No verified English name | 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
215 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Anhui Feng Yuan Pharma Co., Ltd. Huai Hai Pharmaceutical Factory romanized | 10 | 2 | 0 |
| 2 | Hainan Huluwa Pharmaceutical Group Co., Ltd. | 7 | 4 | 5 |
| 3 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 7 | 2 | 0 |
| 4 | Pfizer Inc. | 6 | 3 | 0 |
| 5 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized | 6 | 1 | 0 |
| 6 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 2 | 0 |
| 8 | Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized | 5 | 1 | 0 |
| 9 | Beijing Bai Ao Pharma Co., Ltd. romanized | 4 | 3 | 4 |
| 10 | Jilin Heng Xing Technology Pharmaceutical Co., Ltd. romanized | 4 | 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
131 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/05/18Import · Class 2.4 | 甲磺酸贝舒地尔片 · No verified English nameJXHL2400115 | Kadmon Pharmaceuticals LLC; Sanofi (China) Investment Co. Ltd. |
| 2024/05/18Import · Class 2.4 | Fezolinetant片 · No verified English nameJXHL2400114 | Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd. |
| 2024/05/18Generic · Class 3 | Acetylcysteine InjectionCYHS2401507 | HUNAN WARRANT PHARMACEUTICAL CO.,LTD |
| 2024/05/18Generic · Class 3 | 乌苯美司胶囊 · No verified English nameCYHS2401505 | Xian Wan Long Pharmaceutical Co., Ltd. romanized |
| 2024/05/18Generic · Class 3 | Loxoprofen Sodium Oral SolutionCYHS2401502 | Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized |
| 2024/05/18Generic · Class 3 | Linagliptin and Metformin Hydrochloride Extended Release TabletsCYHS2401498 | Hubei Guang Chen Pharma Co., Ltd. romanized |
| 2024/05/18Generic · Class 3 | Linagliptin and Metformin Hydrochloride Extended Release TabletsCYHS2401497 | Hubei Guang Chen Pharma Co., Ltd. romanized |
| 2024/05/18Generic · Class 3 | 丁酸氯维地平注射用乳剂 · No verified English nameCYHS2401496 | Qilu Pharmaceutical (Hainan) Co., Ltd |
| 2024/05/18Generic · Class 3 | Calcium Gluconate in Sodium Chloride InjectionCYHS2401493 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2024/05/18Generic · Class 3 | 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2401489 | Hubei Lai Kang Medical Technology Co., Ltd. romanized; Guangdong Hua Nan Pharma Group Co., Ltd. romanized |
| 2024/05/18Generic · Class 3 | Dexketoprofen Trometamol InjectionCYHL2400098 | Beijing Bai Ao Pharma Co., Ltd. romanized |
| 2024/05/18New drug · Class 1.2 | JKN2303 · No verified English nameCXZL2400029 | Jiangxi Zhong Pharmaceuticals University romanized; Guangxi Xin Hai Pharma Technology Co., Ltd. romanized |
| 2024/05/18New drug · Class 1.2 | JKN2303吸入溶液 · No verified English nameCXZL2400028 | Guangxi Xin Hai Pharma Technology Co., Ltd. romanized; Health Yuan Pharma Group Co., Ltd. romanized |
| 2024/05/18New drug · Class 1.2 | JKN2303吸入溶液 · No verified English nameCXZL2400027 | Guangxi Xin Hai Pharma Technology Co., Ltd. romanized; Health Yuan Pharma Group Co., Ltd. romanized |
| 2024/05/18New drug · Class 1.2 | JKN2303吸入溶液 · No verified English nameCXZL2400026 | Guangxi Xin Hai Pharma Technology Co., Ltd. romanized; Health Yuan Pharma Group Co., Ltd. romanized |
| 2024/05/18New drug · Class 1.2 | JKN2303吸入溶液 · No verified English nameCXZL2400025 | Guangxi Xin Hai Pharma Technology Co., Ltd. romanized; Health Yuan Pharma Group Co., Ltd. romanized |
| 2024/05/18New drug · Class 3.3 | 四价流感病毒裂解疫苗 · No verified English nameCXSL2400331 | Shenzhen Kang Tai Bio Zhi Pin Co., Ltd. romanized |
| 2024/05/18New drug · Class 1 | PM1032注射液 · No verified English nameCXSL2400330 | Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized |
| 2024/05/18New drug · Class 2.2 | SL001 · No verified English nameCXHL2400511 | Sichuan Sheng San Xing Dui Pharmaceutical Co., Ltd. romanized |
| 2024/05/17Import · Class 1 | 注射用M9140 · No verified English nameJXSL2400096 | Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd. |
| 2024/05/17Import · Class 2.2 | Dostarlimab注射液 · No verified English nameJXSL2400095 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. LTD |
| 2024/05/17Import · Class 2.2 | Dostarlimab注射液 · No verified English nameJXSL2400094 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd. |
| 2024/05/17Import · Class 1 | Amlitelimab注射液 · No verified English nameJXSL2400093 | Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD |
| 2024/05/17Generic · Class 3 | Amisulpride InjectionCYHS2401488 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD. |
| 2024/05/17Generic · Class 3 | Amisulpride InjectionCYHS2401487 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD. |
| 2024/05/17Generic · Class 3 | Bumetanide InjectionCYHS2401480 | Sichuan Ao Bang Gu De Pharma Co., Ltd. romanized; Chengdu Li Er Pharma Co., Ltd. romanized |
| 2024/05/17Generic · Class 3 | 盐酸纳美芬注射液 · No verified English nameCYHS2401479 | Hainan Ai Ke Pharmaceutical Co., Ltd. romanized |
| 2024/05/17Generic · Class 3 | Metaraminol Tartrate InjectionCYHS2401477 | Guangzhou Hui Feng De Bio Technology Co., Ltd. romanized; Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized |
| 2024/05/17Generic · Class 3 | Glyburide and Metformin Hydrochloride TabletsCYHS2401476 | Tong Hua Wan Tong Pharma Co., Ltd. romanized |
| 2024/05/17Generic · Class 3 | Glyburide and Metformin Hydrochloride TabletsCYHS2401475 | Tong Hua Wan Tong Pharma Co., Ltd. romanized |
101 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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