YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 186 drug applications between 21 March 2024 and 27 March 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 57, covering 48 drug names.
2024/03/21 – 2024/03/27
- New acceptances this week
- 186
- Drugs with new generic filings (by drug name, de-duplicated)
- 48
- Accepted this week, now under review
- 1
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
186filings, 57 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 82 |
| Generic | 57 |
| New drug | 23 |
| Import | 13 |
| Unspecified | 6 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 128 |
| TCM | 27 |
| Therapeutic biologic | 27 |
| Biologic | 2 |
| 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
48 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Morinidazole and Sodium Chloride Injection | 2 | 2 | 9 |
| 2 | Potassium Phosphates Injection | 2 | 2 | 2 |
| 3 | Nicorandil for Injection | 2 | 2 | 1 |
| 4 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 5 | Oseltamivir Phosphate Capsules | 2 | 2 | 39 |
| 6 | Levothyroxine Sodium Tablets | 2 | 1 | 12 |
| 7 | Brivaracetam Tablets | 2 | 1 | 19 |
| 8 | Ambroxol Hydrochloride Oral Solution | 2 | 1 | 46 |
| 9 | Sugammadex Sodium Injection | 2 | 1 | 6 |
| 10 | Crisaborole Ointment | 1 | 1 | 26 |
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
132 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guo Da (Jilin) Pharmaceutical Group Co., Ltd. romanized | 5 | 5 | 0 |
| 2 | Yi Chang Nuo An Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 3 | Beijing Foyou Pharma CO.,LTD | 4 | 3 | 4 |
| 4 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized | 4 | 3 | 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 | Merck Sharp & Dohme LLC | 3 | 3 | 0 |
| 9 | Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 3 | 3 | 1 |
| 10 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 3 | 3 | 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
57 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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. |
| 2024/03/27Import · Class 2.2 | 古塞奇尤单抗注射液 · No verified English nameJXSS2400028 | Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd. |
| 2024/03/27Import · Class 2.2 | 古塞奇尤单抗注射液 · No verified English nameJXSS2400027 | Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd. |
| 2024/03/27Import · Class 1 | MK-0616 片 · No verified English nameJXHL2400068 | Merck Sharp & Dohme LLC; Name not romanized |
| 2024/03/27Generic · Class 3 | 草酸艾司西酞普兰口服滴剂 · No verified English nameCYHS2400930 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized |
| 2024/03/27Generic · Class 3 | Epinastine Hydrochloride Eye DropsCYHS2400929 | Run Er Yan Ke Drug (Guangzhou) Co., Ltd. romanized; Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized |
| 2024/03/27Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2400928 | Guangzhou He He Pharmaceuticals Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized |
| 2024/03/27Generic · Class 3 | Minoxidil LinimentCYHS2400926 | Guangzhou Hui Yuan Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Ke Lun Pharma Co., Ltd. romanized |
| 2024/03/27Generic · Class 3 | 盐酸丙卡特罗干糖浆 · No verified English nameCYHS2400922 | Nanjing Ji Cui Ji Ding Pharmaceuticals Co., Ltd. romanized |
| 2024/03/27Generic · Class 3 | Fudosteine oral solutionCYHS2400919 | Jilin Chang Bai Shan Pharma Group Co., Ltd. romanized |
| 2024/03/27Generic · Class 3 | Famotidine InjectionCYHS2400916 | Wuhan Fu Xing Bio Pharma Co., Ltd. romanized |
| 2024/03/27New drug · Class 1 | 注射用HDM2005 · No verified English nameCXSL2400203 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2024/03/27New drug · Class 2.4 | 赛沃替尼片 · No verified English nameCXHS2400022 | He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized; Shanghai He Quan Pharmaceuticals Co., Ltd. romanized |
| 2024/03/27New drug · Class 2.4 | 赛沃替尼片 · No verified English nameCXHS2400021 | He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized; Shanghai He Quan Pharmaceuticals Co., Ltd. romanized |
| 2024/03/27New drug · Class 1 | ASP3082注射液 · No verified English nameCXHL2400308 | An Si Tai Lai (Zhongguo) Investment Co., Ltd. romanized |
| 2024/03/27New drug · Class 2.2 | HZ211口溶膜 · No verified English nameCXHL2400307 | Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/03/27New drug · Class 1 | HSK42360片 · No verified English nameCXHL2400306 | Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2024/03/27New drug · Class 1 | HSK42360片 · No verified English nameCXHL2400305 | Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2024/03/26Import · Class 2.4 | LNP023胶囊 · No verified English nameJXHL2400067 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2024/03/26Generic · Class 3 | Loxoprofen Sodium Oral SolutionCYHS2400913 | Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized |
| 2024/03/26Generic · Class 3 | Milrinone InjectionCYHS2400910 | Jilin Zhen Ao Pharmaceutical Co., Ltd. romanized |
| 2024/03/26Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2400907 | Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized |
| 2024/03/26Generic · Class 3 | Brivaracetam TabletsCYHL2400065 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2024/03/26Generic · Class 3 | Brivaracetam TabletsCYHL2400064 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2024/03/26New drug · Class 1 | HS-10518胶囊 · No verified English nameCXHL2400304 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/03/26New drug · Class 1 | HS-10518胶囊 · No verified English nameCXHL2400303 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/03/26New drug · Class 1 | HS-10518胶囊 · No verified English nameCXHL2400302 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/03/26New drug · Class 1 | HRS7415片 · No verified English nameCXHL2400301 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/03/26New drug · Class 1 | HRS-8080片 · No verified English nameCXHL2400300 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2024/03/26New drug · Class 1 | HRS-8080片 · No verified English nameCXHL2400299 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
27 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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