YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 227 drug applications between 10 February 2022 and 16 February 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 44, covering 30 drug names.
2022/02/10 – 2022/02/16
- New acceptances this week
- 227
- Drugs with new generic filings (by drug name, de-duplicated)
- 30
- 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
227filings, 44 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 138 |
| Generic | 44 |
| New drug | 38 |
| Import | 6 |
| Unspecified | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 161 |
| Therapeutic biologic | 44 |
| TCM | 21 |
| Prophylactic 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
30 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Rosuvastatin Calcium Tablets | 4 | 2 | 18 |
| 2 | Sodium Hyaluronate Eye Drops | 3 | 3 | 30 |
| 3 | 氧 · No verified English name | 2 | 2 | 15 |
| 4 | Regorafenib Tablets | 2 | 2 | 3 |
| 5 | Nintedanib Esilate Soft Capsules | 2 | 1 | 6 |
| 6 | Etoricoxib Tablets | 2 | 1 | 8 |
| 7 | 利奈唑胺干混悬剂 · No verified English name | 2 | 1 | 1 |
| 8 | Obeticholic Acid Tablets | 2 | 1 | 0 |
| 9 | Levofloxacin and Sodium Chloride Injection | 2 | 1 | 14 |
| 10 | Sildenafil Citrate Tablets | 2 | 1 | 12 |
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
142 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guangxi Zhuang Zu Zi Zhi Qu Hua Hong Jin Rui Pharma Co., Ltd. romanized | 10 | 8 | 0 |
| 2 | Changchun Jin Sai Pharma Co., Ltd. romanized | 8 | 2 | 0 |
| 3 | Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized | 6 | 3 | 0 |
| 4 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized | 6 | 1 | 0 |
| 5 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 5 | 2 | 0 |
| 6 | Qilu Pharmaceutical Co., Ltd. | 4 | 3 | 3 |
| 7 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 4 | 2 | 0 |
| 8 | AstraZeneca UK Limited | 4 | 1 | 0 |
| 9 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | UCB Pharma S.A. | 3 | 2 | 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
52 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/02/16New drug · Class 2.3 | 大株红景天胶囊 · No verified English nameCXZL2200010 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2022/02/16New drug · Class 1 | EVER001胶囊 · No verified English nameCXHL2200098 | Yun Ding Xin Yao Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/02/16New drug · Class 1 | SR750片 · No verified English nameCXHL2200095 | Shanghai Sai Mo Luo De Bio Technology Co., Ltd. romanized |
| 2022/02/16New drug · Class 1 | SR750片 · No verified English nameCXHL2200094 | Shanghai Sai Mo Luo De Bio Technology Co., Ltd. romanized |
| 2022/02/15Generic · Class 3 | Ambroxol Hydrochloride Oral SolutionCYHS2200305 | Anhui Yong Sheng Tang Pharma Co., Ltd. romanized |
| 2022/02/15New drug · Class 2.3 | 金振口服液 · No verified English nameCXZL2200009 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2022/02/15New drug · Class 1 | 人源TH-SC01细胞注射液 · No verified English nameCXSL2200093 | Jiangsu Tuo Hong Kang Heng Pharmaceuticals Co., Ltd. romanized |
| 2022/02/15New drug · Class 1 | CPD-002注射液 · No verified English nameCXSL2200092 | Jiangxi Long Chang Pharma Co., Ltd. romanized |
| 2022/02/15New drug · Class 1 | 注射用8MW2311 · No verified English nameCXSL2200091 | Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized |
| 2022/02/15New drug · Class 1 | SYHX2005 · No verified English nameCXHL2200097 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2022/02/15New drug · Class 1 | SYHX2005 · No verified English nameCXHL2200096 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2022/02/15New drug · Class 1 | XTR006注射液 · No verified English nameCXHL2200090 | Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/02/15New drug · Class 1 | BEBT-305片 · No verified English nameCXHL2200089 | Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized |
| 2022/02/15New drug · Class 1 | BEBT-305片 · No verified English nameCXHL2200088 | Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized |
| 2022/02/14Generic · Class 3 | 利奈唑胺干混悬剂 · No verified English nameCYHS2200309 | Zhejiang Pu Li Pharma Co., Ltd. romanized |
| 2022/02/14Generic · Class 3 | 利奈唑胺干混悬剂 · No verified English nameCYHS2200308 | Zhejiang Pu Li Pharma Co., Ltd. romanized |
| 2022/02/14Generic · Class 3 | Pregabalin Extended release TabletsCYHL2200017 | Beijing Tai De Pharmaceutical Co., Ltd. romanized |
| 2022/02/14New drug · Class 1 | 异体内皮祖细胞(EPCs)注射液 · No verified English nameCXSL2200090 | Cheng Nuo Zai Sheng Yi Xue Technology (Zhuhai Heng Qin Xin Qu) Co., Ltd. romanized |
| 2022/02/14New drug · Class 1 | 注射用重组人源化抗HER2单抗-AS269偶联物(ARX788) · No verified English nameCXSL2200080 | Zhejiang Xin Ma Biopharmaceuticals Co., Ltd. romanized |
| 2022/02/14New drug · Class 1 | TT-01488片 · No verified English nameCXHL2200093 | Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized |
| 2022/02/14New drug · Class 1 | TT-01488片 · No verified English nameCXHL2200091 | Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized |
| 2022/02/14New drug · Class 1 | 注射用聚乙二醇伊立替康 · No verified English nameCXHL2200081 | Tianjin Jian Kai Technology Co., Ltd. romanized |
| 2022/02/11Import · Class 2.4 | NBTXR3 · No verified English nameJXHL2200037 | Nanobiotix S.A.; Shanghai LianBio Development Co. Ltd. |
| 2022/02/11Generic · Class 3 | Oxytocin InjectionCYHS2200300 | Xian Nuo Da Xin Pharmaceuticals Technology Co., Ltd. romanized; Xian Han Feng Pharma Co., Ltd. romanized |
| 2022/02/11Generic · Class 3 | Oxytocin InjectionCYHS2200299 | Xian Nuo Da Xin Pharmaceuticals Technology Co., Ltd. romanized; Xian Han Feng Pharma Co., Ltd. romanized |
| 2022/02/11Generic · Class 3 | Biapenem For InjectionCYHS2200297 | Shenzhen Hua Yao Nan Fang Pharmaceutical Co., Ltd. romanized |
| 2022/02/11Generic · Class 3 | lorazepam injectionCYHL2200016 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2022/02/11New drug · Class 1 | 重组全人抗LAG-3单克隆抗体注射液 · No verified English nameCXSL2200089 | Guangzhou Yu Heng Bio Technology Co., Ltd. romanized |
| 2022/02/11New drug · Class 1 | IBI322 · No verified English nameCXSL2200088 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2022/02/11New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2200087 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
22 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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