YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 288 drug applications between 5 April 2023 and 11 April 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 71, covering 50 drug names.
2023/04/05 – 2023/04/11
- New acceptances this week
- 288
- Drugs with new generic filings (by drug name, de-duplicated)
- 50
- 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
288filings, 71 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 164 |
| Generic | 71 |
| New drug | 33 |
| Import | 8 |
| Unspecified | 6 |
| Import re-registration | 5 |
| Drug-device combination product | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 219 |
| Therapeutic biologic | 49 |
| TCM | 18 |
| 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
50 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide Tablets | 5 | 1 | 5 |
| 2 | 氧(液态) · No verified English name | 2 | 2 | 13 |
| 3 | Polyvinyl Alcohol Eye Drops | 2 | 2 | 24 |
| 4 | Tadalafil Tablets | 2 | 1 | 23 |
| 5 | Everolimus Tablets | 2 | 1 | 2 |
| 6 | Ozagrel Sodium Injection | 2 | 1 | 3 |
| 7 | Levocarnitine Oral Solution | 2 | 1 | 9 |
| 8 | Ibuprofen Injection | 2 | 1 | 8 |
| 9 | Torsemide Injection | 2 | 1 | 1 |
| 10 | Potassium Chloride Granules | 2 | 1 | 4 |
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
160 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hainan Heng Cheng San Ye Pharmaceutical Co., Ltd. romanized | 35 | 32 | 0 |
| 2 | Luye Pharma Limited | 7 | 1 | 0 |
| 3 | Jiangxi Ren Qi Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized | 5 | 2 | 0 |
| 5 | Organon Pharma (UK) Limited | 5 | 1 | 0 |
| 6 | Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized | 5 | 1 | 5 |
| 7 | Beijing Han Mei Medicines Co., Ltd. romanized | 4 | 4 | 3 |
| 8 | Qilu Pharmaceutical Co., Ltd. | 4 | 2 | 0 |
| 9 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Zhejiang Hang Kang Pharma Co., Ltd. romanized | 4 | 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
73 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/04/11Import · Class 2.2 | 法瑞西单抗注射液 · No verified English nameJXSS2300030 | Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche AG |
| 2023/04/11Import · Class 3.1 | 注射用A型肉毒毒素 · No verified English nameJXSS2300029 | Revance Therapeutics Inc.; Shanghai Fosun Pharmaceutical Industrial Development Company Limited |
| 2023/04/11Import · Class 1 | AZD4573 · No verified English nameJXHL2300076 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/04/11New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSS2300018 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/04/11New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSS2300017 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/04/11New drug · Class 1 | IM83嵌合抗原受体T细胞注射液(IM83 CAR-T细胞注射液) · No verified English nameCXSL2300249 | Beijing Yi Miao Shen Zhou Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/04/11New drug · Class 1 | 注射用重组WNV-HCD86 · No verified English nameCXSL2300248 | Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized |
| 2023/04/11New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2300247 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/04/11New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2300246 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/04/11New drug · Class 2.4 | Sivelestat Sodium for InjectionCXHL2300361 | Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized |
| 2023/04/10Generic · Class 3 | Ibuprofen InjectionCYHS2301016 | Shanxi De Yuan Tang Pharma Co., Ltd. romanized |
| 2023/04/10Generic · Class 3 | Ibuprofen InjectionCYHS2301015 | Shanxi De Yuan Tang Pharma Co., Ltd. romanized |
| 2023/04/10Generic · Class 3 | 依折麦布瑞舒伐他汀钙片(Ⅲ) · No verified English nameCYHS2301014 | Beijing Han Mei Medicines Co., Ltd. romanized |
| 2023/04/10Generic · Class 3 | 依折麦布瑞舒伐他汀钙片(Ⅱ) · No verified English nameCYHS2301013 | Beijing Han Mei Medicines Co., Ltd. romanized |
| 2023/04/10Generic · Class 3 | 依折麦布瑞舒伐他汀钙片(Ⅰ) · No verified English nameCYHS2301012 | Beijing Han Mei Medicines Co., Ltd. romanized |
| 2023/04/10Generic · Class 3 | Torsemide InjectionCYHS2301009 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2023/04/10Generic · Class 3 | Torsemide InjectionCYHS2301008 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2023/04/10Generic · Class 3 | Ferrous Succinate TabletsCYHS2301006 | Beijing Foyou Pharma CO.,LTD |
| 2023/04/10Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2301005 | Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2023/04/10Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2301004 | Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2023/04/10Generic · Class 3 | Progesterone InjectionCYHS2301003 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2023/04/10Generic · Class 3 | Pentoxifylline InjectionCYHS2301000 | Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized |
| 2023/04/10Generic · Class 3 | Dexamethasone Sodium Phosphate InjectionCYHS2300998 | Hui Yu Yuan He (Hainan) Pharma Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2023/04/10Generic · Class 3 | Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHL2300052 | Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized |
| 2023/04/10Generic · Class 3 | Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHL2300051 | Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized |
| 2023/04/10Generic · Class 3 | Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHL2300050 | Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized |
| 2023/04/10Generic · Class 3 | Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHL2300049 | Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized |
| 2023/04/10Generic · Class 3 | Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHL2300048 | Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized |
| 2023/04/10Generic · Class 3 | Alprostadil InjectionCYHL2300047 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2023/04/10Generic · Class 3 | Colesevelam Hydrochloride TabletsCYHL2300046 | ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
43 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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