YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 220 drug applications between 22 March 2024 and 28 March 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 67, covering 54 drug names.
2024/03/22 – 2024/03/28
- New acceptances this week
- 220
- 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
220filings, 67 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 89 |
| Generic | 67 |
| New drug | 31 |
| Import | 20 |
| Import re-registration | 7 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 154 |
| Therapeutic biologic | 33 |
| TCM | 28 |
| 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
54 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Bumetanide Injection | 3 | 2 | 13 |
| 2 | Nicorandil for Injection | 2 | 2 | 1 |
| 3 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 4 | Oseltamivir Phosphate Capsules | 2 | 2 | 39 |
| 5 | Levothyroxine Sodium Tablets | 2 | 1 | 12 |
| 6 | Ibuprofen Injection | 2 | 1 | 8 |
| 7 | Brivaracetam Tablets | 2 | 1 | 19 |
| 8 | Ticagrelor Tablets | 2 | 1 | 10 |
| 9 | Neostigmine Methylsulfate Injection | 2 | 1 | 4 |
| 10 | Ambroxol Hydrochloride Oral Solution | 2 | 1 | 46 |
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
150 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Merck Sharp & Dohme LLC | 5 | 5 | 0 |
| 2 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 5 | 5 | 5 |
| 3 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 5 | 2 | 0 |
| 4 | Yi Chang Nuo An Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 5 | Albireo AB | 4 | 1 | 0 |
| 6 | LG Chem Ltd. | 4 | 1 | 0 |
| 7 | He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized | 4 | 1 | 0 |
| 8 | Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 3 | 3 | 1 |
| 9 | Janssen-Cilag International NV | 3 | 2 | 0 |
| 10 | Beijing Foyou Pharma CO.,LTD | 3 | 2 | 3 |
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
79 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/03/28Import · Class 3.1 | 帕博利珠单抗注射液 · No verified English nameJXSS2400033 | Merck Sharp & Dohme LLC; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd |
| 2024/03/28Import · Class 3.1 | 冻干膀胱灌注用卡介苗(日本株) · No verified English nameJXSS2400032 | Japan BCG Laboratory; Japan BCG Laboratory,Kiyose Plant; Name not romanized |
| 2024/03/28Import · Class 3.1 | 注射用维恩妥尤单抗 · No verified English nameJXSS2400031 | Astellas Pharma Europe B.V.; Baxter Oncology GmbH; Astellas (China) Investment Co. Ltd. |
| 2024/03/28Import · Class 3.1 | 注射用维恩妥尤单抗 · No verified English nameJXSS2400030 | Astellas Pharma Europe B.V.; Baxter Oncology GmbH; Astellas (China) Investment Co Ltd. |
| 2024/03/28Import · Class 1 | Balcinrenone达格列净胶囊 · No verified English nameJXHL2400070 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/03/28Import · Class 1 | Balcinrenone达格列净胶囊 · No verified English nameJXHL2400069 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/03/28Generic · Class 3 | Bumetanide InjectionCYHS2400947 | Ka Wen Di Xu (Tai Zhou) Pharma Co., Ltd. romanized; Jiangsu Yue Xing Pharma Co., Ltd. romanized |
| 2024/03/28Generic · Class 3 | 硫酸沙丁胺醇口服溶液 · No verified English nameCYHS2400946 | Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/03/28Generic · Class 3 | Haloperidol TabletsCYHS2400944 | Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized |
| 2024/03/28Generic · Class 3 | Bumetanide InjectionCYHS2400943 | Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized |
| 2024/03/28Generic · Class 3 | Bumetanide InjectionCYHS2400942 | Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized |
| 2024/03/28Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2400940 | Hainan Mei Kang Da Pharma Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized |
| 2024/03/28Generic · Class 3 | Neostigmine Methylsulfate InjectionCYHS2400939 | Hunan Ai Wei Ge Lin Pharmaceuticals Technology Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD |
| 2024/03/28Generic · Class 3 | Neostigmine Methylsulfate InjectionCYHS2400938 | Hunan Ai Wei Ge Lin Pharmaceuticals Technology Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD |
| 2024/03/28Generic · Class 3 | Minoxidil LinimentCYHS2400936 | Guangzhou Hui Yuan Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Ke Lun Pharma Co., Ltd. romanized |
| 2024/03/28Generic · Class 3 | Diprophylline InjectionCYHS2400931 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2024/03/28Generic · Class 3 | Ibuprofen InjectionCYHL2400067 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED |
| 2024/03/28Generic · Class 3 | Ibuprofen InjectionCYHL2400066 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED |
| 2024/03/28New drug · Class 1 | 注射用聚乙二醇化促血小板生成肽 · No verified English nameCXSL2400205 | Chongqing Pai Jin Bio Technology Co., Ltd. romanized |
| 2024/03/28New drug · Class 1 | 注射用重组酰化胰高血糖素样肽2类似物 · No verified English nameCXSL2400204 | Chongqing Pai Jin Bio Technology Co., Ltd. romanized |
| 2024/03/28New drug · Class 1 | SK-08片 · No verified English nameCXHL2400317 | Kang Chen Pharma (Nei Menggu) Co., Ltd. romanized |
| 2024/03/28New drug · Class 1 | SK-08片 · No verified English nameCXHL2400316 | Kang Chen Pharma (Nei Menggu) Co., Ltd. romanized |
| 2024/03/28New drug · Class 1 | SK-08片 · No verified English nameCXHL2400315 | Kang Chen Pharma (Nei Menggu) Co., Ltd. romanized |
| 2024/03/28New drug · Class 2.2 | 磷酸奥司他韦口溶膜 · No verified English nameCXHL2400314 | Gansu Pu Di An Pharmaceutical Co., Ltd. romanized |
| 2024/03/28New drug · Class 2.2 | 磷酸奥司他韦口溶膜 · No verified English nameCXHL2400313 | Gansu Pu Di An Pharmaceutical Co., Ltd. romanized |
| 2024/03/28New drug · Class 2.2 | 磷酸奥司他韦口溶膜 · No verified English nameCXHL2400312 | Gansu Pu Di An Pharmaceutical Co., Ltd. romanized |
| 2024/03/28New drug · Class 1 | AXT-1003胶囊 · No verified English nameCXHL2400311 | Ai Si Tuo Kang Pharmaceuticals Technology (Beijing) Co., Ltd. romanized |
| 2024/03/28New drug · Class 1 | JAB-30355片 · No verified English nameCXHL2400310 | Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized |
| 2024/03/28New drug · Class 1 | JAB-30355片 · No verified English nameCXHL2400309 | Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized |
| 2024/03/27Import · Class 2.1; 2.2 | 古塞奇尤单抗注射液(静脉输注) · No verified English nameJXSS2400029 | Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd. |
49 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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