YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 379 drug applications between 27 January 2023 and 2 February 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 99, covering 75 drug names.
2023/01/27 – 2023/02/02
- New acceptances this week
- 379
- Drugs with new generic filings (by drug name, de-duplicated)
- 75
- 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
379filings, 99 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 161 |
| Generic | 99 |
| New drug | 78 |
| Import re-registration | 18 |
| Import | 16 |
| Unspecified | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 302 |
| Therapeutic biologic | 37 |
| TCM | 36 |
| Prophylactic biologic | 4 |
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
75 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 5 | 3 | 23 |
| 2 | Minoxidil Topical Solution | 4 | 2 | 0 |
| 3 | Peramivir Injection | 3 | 2 | 7 |
| 4 | Doxofylline Injection | 2 | 2 | 5 |
| 5 | Famotidine Injection | 2 | 2 | 8 |
| 6 | Phloroglucinol Injection | 2 | 2 | 2 |
| 7 | Avatrombopag Maleate Tablets | 2 | 2 | 0 |
| 8 | Acetylcysteine Granules | 2 | 1 | 4 |
| 9 | Lactulose Oral Solution | 2 | 1 | 34 |
| 10 | Voriconazole Tablets | 2 | 1 | 1 |
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
229 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Ping Guang Pharmaceutical Co., Ltd. romanized | 13 | 12 | 0 |
| 2 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 8 | 3 | 0 |
| 3 | Shanghai Bo Lai Ke Xin Yi Pharma Co., Ltd. romanized | 8 | 1 | 0 |
| 4 | Yue Ming Tang (Shanxi) Zhong Yao Co., Ltd. romanized | 7 | 7 | 0 |
| 5 | Sichuan Kelun Pharmaceutical Co., Ltd. | 7 | 5 | 1 |
| 6 | Anhui Pioneer Pharmaceutical Co., Ltd | 6 | 2 | 0 |
| 7 | Bracco Imaging Italia s.r.l. | 6 | 1 | 0 |
| 8 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 5 | 4 | 3 |
| 9 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized | 5 | 2 | 0 |
| 10 | Guangzhou Bai Te Qiao Guang Medical Yong Pin Co., Ltd. romanized | 5 | 1 | 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
133 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/02/02Import · Class 2.2 | 度伐利尤单抗注射液 · No verified English nameJXSL2300031 | AstraZeneca UK Limited; AstraZeneca Investment (China) Co. Limited |
| 2023/02/02Import · Class 1 | ALXN1720注射液 · No verified English nameJXSL2300030 | Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/02/02Generic · Class 3 | Ornidazole InjectionCYHS2300311 | Hunan Jiudian Pharmaceutical Co., Ltd; Kang Pu Pharma Co., Ltd. romanized |
| 2023/02/02Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2300309 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2023/02/02Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2300308 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2023/02/02Generic · Class 3 | 复方匹可硫酸钠颗粒 · No verified English nameCYHS2300307 | Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized |
| 2023/02/02Generic · Class 3 | Peramivir InjectionCYHS2300306 | Lang Tian Pharma (Hubei) Co., Ltd. romanized |
| 2023/02/02Generic · Class 3 | Bromhexine Hydrochloride TabletsCYHS2300305 | Chengdu Giantech Hi-technology Development Co., Ltd.; Sichuan Wei Ao Pharmaceutical Co., Ltd. romanized |
| 2023/02/02Generic · Class 3 | Peramivir InjectionCYHS2300304 | Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/02/02Generic · Class 3 | Peramivir InjectionCYHS2300303 | Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/02/02Generic · Class 3 | Dobutamine Hydrochloride InjectionCYHS2300301 | Zhejiang Feng Hua Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/02/02Generic · Class 3 | Indobufen TabletsCYHS2300300 | Hunan Jiudian Pharmaceutical Co., Ltd |
| 2023/02/02Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300296 | Hua Cui International Bio Technology (Guangdong) Co., Ltd. romanized; Xi Nan Pharma Co., Ltd. romanized |
| 2023/02/02Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300295 | Hua Cui International Bio Technology (Guangdong) Co., Ltd. romanized; Xi Nan Pharma Co., Ltd. romanized |
| 2023/02/02Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300294 | Hua Cui International Bio Technology (Guangdong) Co., Ltd. romanized; Xi Nan Pharma Co., Ltd. romanized |
| 2023/02/02Generic · Class 3 | Furosemide Oral SolutionCYHS2300293 | Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized |
| 2023/02/02Generic · Class 3 | Minoxidil Topical SolutionCYHS2300289 | Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/02/02Generic · Class 3 | Minoxidil Topical SolutionCYHS2300288 | Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/02/02Generic · Class 3 | Arformoterol Tartrate Inhalation SolutionCYHL2300014 | Jiangsu He Chen Pharma Co., Ltd. romanized |
| 2023/02/02Generic · Class 3 | Epinastine Hydrochloride Eye DropsCYHL2300013 | Run Er Yan Ke Drug (Guangzhou) Co., Ltd. romanized |
| 2023/02/02New drug · Class 2.3 | 肾衰宁胶囊 · No verified English nameCXZL2300007 | Yunnan Lei Yun Shang Li Xiang Pharma Co., Ltd. romanized |
| 2023/02/02New drug · Class 1 | JS006注射液 · No verified English nameCXSL2300076 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/02/02New drug · Class 2.2 | 双歧杆菌四联活菌散 · No verified English nameCXSL2300075 | Hangzhou Yuan Da Biopharmaceutical Co., Ltd. romanized |
| 2023/02/02New drug · Class 1 | AK114注射液 · No verified English nameCXSL2300074 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2023/02/02New drug · Class 1 | SHR-2002注射液 · No verified English nameCXSL2300073 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2023/02/02New drug · Class 1 | 磷酸盛格列汀片 · No verified English nameCXHS2300023 | Sheng Shi Tai Ke Biopharmaceuticals Technology (Suzhou) Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2023/02/02New drug · Class 1 | 磷酸盛格列汀片 · No verified English nameCXHS2300022 | Sheng Shi Tai Ke Biopharmaceuticals Technology (Suzhou) Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2023/02/02New drug · Class 1 | RSS0343片 · No verified English nameCXHL2300157 | Rui Shi Biopharmaceuticals Co., Ltd. romanized |
| 2023/02/02New drug · Class 1 | RSS0343片 · No verified English nameCXHL2300156 | Rui Shi Biopharmaceuticals Co., Ltd. romanized |
| 2023/02/02New drug · Class 1 | RSS0343片 · No verified English nameCXHL2300155 | Rui Shi Biopharmaceuticals Co., Ltd. romanized |
103 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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