YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 299 drug applications between 19 May 2024 and 25 May 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 70, covering 54 drug names.
2024/05/19 – 2024/05/25
- New acceptances this week
- 299
- 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
299filings, 70 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 155 |
| Generic | 70 |
| New drug | 41 |
| Import re-registration | 17 |
| Import | 11 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 185 |
| TCM | 64 |
| Therapeutic biologic | 45 |
| 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
54 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Bupivacaine Hydrochloride Injection | 4 | 2 | 4 |
| 2 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 2 | 2 | 23 |
| 3 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 4 | 复方氨基酸(15AA-II)/葡萄糖(10%)电解质注射液 · No verified English name | 2 | 1 | 0 |
| 5 | Nicergoline Tablets | 2 | 1 | 1 |
| 6 | Levetiracetam extended-release tablets | 2 | 1 | 0 |
| 7 | Baricitinib Tablets | 2 | 1 | 32 |
| 8 | 帕拉米韦氯化钠注射液 · No verified English name | 2 | 1 | 17 |
| 9 | 平衡盐冲洗液 · No verified English name | 2 | 1 | 0 |
| 10 | Famotidine Injection | 2 | 1 | 8 |
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
181 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Qin Huang Dao Shan Hai Guan Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 2 | Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized | 6 | 2 | 0 |
| 3 | Bracco Imaging S.P.A. | 6 | 1 | 0 |
| 4 | AbbVie Inc. | 5 | 3 | 0 |
| 5 | Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | 5 | 2 | 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 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | HUNAN WARRANT PHARMACEUTICAL CO.,LTD | 4 | 2 | 2 |
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
86 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/05/25Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2401573 | Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2024/05/25Generic · Class 3 | Acetylcysteine InjectionCYHS2401572 | Hubei Jin Yao Pharma Co., Ltd. romanized |
| 2024/05/25New drug · Class 1 | LY01620 · No verified English nameCXSL2400349 | Nanjing Ji Mai Bio Technology Co., Ltd. romanized |
| 2024/05/25New drug · Class 1 | 注射用ZGGS18 · No verified English nameCXSL2400348 | Name not romanized |
| 2024/05/25New drug · Class 1 | 注射用ZG005 · No verified English nameCXSL2400347 | Name not romanized |
| 2024/05/25New drug · Class 1 | RC148注射液 · No verified English nameCXSL2400346 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2024/05/25New drug · Class 1 | 注射用RC118 · No verified English nameCXSL2400345 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2024/05/25New drug · Class 2.4 | 青蒿琥酯片 · No verified English nameCXHL2400527 | Gui Lin Nan Yao Co., Ltd. romanized; Shanghai Jiao Tong University romanized |
| 2024/05/24Import · Class 1 | Astegolimab注射液 · No verified English nameJXSL2400103 | F. Hoffmann-La Roche Ltd; Roche(China) Holding Ltd. |
| 2024/05/24Import · Class 2.2 | Epcoritamab注射用浓溶液 · No verified English nameJXSL2400102 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2024/05/24Import · Class 2.2 | Epcoritamab注射用浓溶液 · No verified English nameJXSL2400101 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2024/05/24Import · Class 2.2 | Epcoritamab注射液 · No verified English nameJXSL2400100 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2024/05/24Import · Class 2.2 | Epcoritamab注射液 · No verified English nameJXSL2400099 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2024/05/24Generic · Class 3 | Bupivacaine Hydrochloride InjectionCYHS2401571 | Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2024/05/24Generic · Class 3 | Bupivacaine Hydrochloride InjectionCYHS2401570 | Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2024/05/24Generic · Class 3 | Nicergoline TabletsCYHS2401569 | Hainan Tong Yong San Yang Pharma Co., Ltd. romanized |
| 2024/05/24Generic · Class 3 | Nicergoline TabletsCYHS2401567 | Hainan Tong Yong San Yang Pharma Co., Ltd. romanized |
| 2024/05/24Generic · Class 3 | Betahistine Dihydrochloride TabletsCYHS2401560 | Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized |
| 2024/05/24Generic · Class 3 | Procaterol Hydrochloride Solution for InhalationCYHS2401557 | Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized |
| 2024/05/24Generic · Class 3 | 复方氨基酸(15AA-II)/葡萄糖(10%)电解质注射液 · No verified English nameCYHS2401556 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2024/05/24Generic · Class 3 | Bupivacaine Hydrochloride InjectionCYHS2401555 | Guangzhou Ai Ge Bio Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2024/05/24Generic · Class 3 | 复方氨基酸(15AA-II)/葡萄糖(10%)电解质注射液 · No verified English nameCYHS2401554 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2024/05/24Generic · Class 3 | Bupivacaine Hydrochloride InjectionCYHS2401553 | Guangzhou Ai Ge Bio Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2024/05/24Generic · Class 3 | 米诺地尔泡沫剂(女用) · No verified English nameCYHL2400101 | Shanxi Zhen Dong An Xin Biopharmaceutical Co., Ltd. romanized |
| 2024/05/24Generic · Class 3 | 米诺地尔泡沫剂(男用) · No verified English nameCYHL2400100 | Shanxi Zhen Dong An Xin Biopharmaceutical Co., Ltd. romanized |
| 2024/05/24New drug · Class 1 | 注射用HS-20124 · No verified English nameCXSL2400344 | Changzhou Heng Bang Pharma Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/05/24New drug · Class 1 | GenSci098注射液 · No verified English nameCXSL2400343 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2024/05/24New drug · Class 1 | JH013注射液 · No verified English nameCXSL2400342 | Bai Tai Bio Pharma Co., Ltd. romanized; An Bo Tai Ke Pharma Co., Ltd. romanized |
| 2024/05/24New drug · Class 1 | SHR-3821注射液 · No verified English nameCXSL2400341 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2024/05/24New drug · Class 1.2 | 重组破伤风疫苗(大肠埃希菌) · No verified English nameCXSL2400340 | Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Nanjing) Co., Ltd. romanized; Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Hangzhou) Co., Ltd. romanized |
56 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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