YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 346 drug applications between 25 June 2021 and 1 July 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 48, covering 37 drug names.
2021/06/25 – 2021/07/01
- New acceptances this week
- 346
- Drugs with new generic filings (by drug name, de-duplicated)
- 37
- 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
346filings, 48 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 189 |
| New drug | 54 |
| Generic | 48 |
| Import | 36 |
| Unspecified | 12 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 224 |
| Therapeutic biologic | 61 |
| TCM | 58 |
| Prophylactic biologic | 3 |
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
37 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Compound Ipratropium Bromide Solution For Inhalation | 2 | 2 | 4 |
| 2 | Tenofovir alafenamide Fumarate Tablets | 2 | 2 | 0 |
| 3 | Clindamycin Injection | 2 | 1 | 4 |
| 4 | Selexipag Tablets | 2 | 1 | 24 |
| 5 | Ipratropium Bromide Inhalation Solution | 2 | 1 | 2 |
| 6 | Ornidazole Injection | 2 | 1 | 0 |
| 7 | Epinastine Hydrochloride Tablets | 2 | 1 | 2 |
| 8 | Ropivacaine hydrochloride injection | 2 | 1 | 5 |
| 9 | Dabigatran Etexilate Capsules | 2 | 1 | 2 |
| 10 | Ketorolac Tromethamine Injection | 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
188 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Zhejiang You Sheng Mei Te Zhong Yao Co., Ltd. romanized | 37 | 34 | 0 |
| 2 | Guizhou Liang Ji Pharma Co., Ltd. romanized | 14 | 14 | 0 |
| 3 | Roche Pharma (Schweiz) Ltd. | 6 | 1 | 0 |
| 4 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 5 | 3 | 0 |
| 5 | Boehringer Ingelheim International GmbH | 5 | 2 | 0 |
| 6 | Janssen Research & Development LLC | 5 | 2 | 0 |
| 7 | Baxalta US Inc. | 5 | 1 | 0 |
| 8 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Mao Xiang Group Jilin Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Pliva Croatia Ltd. | 4 | 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
103 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/07/01Import · Class 1 | MK-1308A注射液 · No verified English nameJXSL2101062 | Merck Sharp & Dohme Corp.; MSD R&D（China）Co. Ltd. |
| 2021/07/01Import · Class 3.1 | 九价人乳头瘤病毒疫苗（酿酒酵母） · No verified English nameJXSL2101061 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2021/07/01Import · Class 3.1 | 九价人乳头瘤病毒疫苗（酿酒酵母） · No verified English nameJXSL2101060 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2021/07/01Generic · Class 3 | 头孢丙烯干混悬剂 · No verified English nameCYHS2101376 | Shenzhen Li Jian Pharma Co., Ltd. romanized |
| 2021/07/01Generic · Class 3 | Aripiprazole Oral SolutionCYHS2101372 | Sichuan Da Zhong Pharmaceutical Co., Ltd. romanized |
| 2021/07/01Generic · Class 3 | Fluoxetine Hydrochloride Oral SolutionCYHS2101369 | Anhui Xin Shi Ji Pharma Co., Ltd. romanized |
| 2021/07/01New drug · Class 3.4 | 人凝血因子Ⅷ · No verified English nameCXSS2101006 | Hua Run Bo Ya Biopharmaceutical Group Co., Ltd. romanized |
| 2021/07/01New drug · Class 3.3 | 注射用人高血糖素 · No verified English nameCXSL2101165 | Shanghai Duo Mi Rui Bio Technology Co., Ltd. romanized |
| 2021/07/01New drug · Class 2.4 | Remimazolam Besylate For InjectionCXHS2101026 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2021/07/01New drug · Class 1 | HTMC0503片 · No verified English nameCXHL2101250 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2021/07/01New drug · Class 1 | HTMC0503片 · No verified English nameCXHL2101249 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2021/07/01New drug · Class 1 | HTMC0503片 · No verified English nameCXHL2101248 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2021/06/30Import · Class 2.2 | 阿替利珠单抗注射液 · No verified English nameJXSS2101014 | Roche Registration GmbH; Roche Diagnostics GmbH; Roche (China) Holding Ltd. |
| 2021/06/30Import · Class 1 | RO7030816 · No verified English nameJXSL2101058 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2021/06/30Import · Class 1 | RO7030816 · No verified English nameJXSL2101057 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2021/06/30Import · Class 1 | avalglucosidase alfa for injection · No verified English nameJXSL2101056 | Sanofi-aventis Recherche & Développement; Sanofi (China) investment Co. Ltd |
| 2021/06/30Import · Class 1 | NNC0385-0434 片 · No verified English nameJXSL2101054 | Novo Nordisk A/S; Novo Nordisk（China）Pharmaceuticals Co. Ltd. |
| 2021/06/30Import · Class 1 | NNC0385-0434 片 · No verified English nameJXSL2101053 | Novo Nordisk A/S; Novo Nordisk（China）Pharmaceuticals Co. Ltd. |
| 2021/06/30Import · Class 1 | NNC0385-0434 片 · No verified English nameJXSL2101052 | Novo Nordisk A/S; Novo Nordisk（China）Pharmaceuticals Co. Ltd. |
| 2021/06/30Generic · Class 3 | ω-3 鱼油中长链脂肪乳/氨基酸（16）/葡萄糖（30%）注射液 · No verified English nameCYHS2101368 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/06/30New drug · Class 1 | TP01HN106 · No verified English nameCXSL2101164 | Shenzhen Rui Jian Sheng Ming Ke Xue Research Institute Co., Ltd. romanized |
| 2021/06/30New drug · Class 2.2 | 贝伐珠单抗注射液 · No verified English nameCXSL2101163 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2021/06/30New drug · Class 1 | 注射用BEBT-908 · No verified English nameCXHL2101244 | Guangzhou Bi Bei Te Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/06/29Import · Class 2.2 | 纳武利尤单抗注射液 · No verified English nameJXSL2101047 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2021/06/29Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2101363 | Haerbin Sheng Tai Biopharmaceutical Co., Ltd. romanized |
| 2021/06/29Generic · Class 3 | Clindamycin InjectionCYHS2101359 | Anhui Pioneer Pharmaceutical Co., Ltd |
| 2021/06/29Generic · Class 3 | Clindamycin InjectionCYHS2101358 | Anhui Pioneer Pharmaceutical Co., Ltd |
| 2021/06/29Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2101356 | Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2021/06/29New drug · Class 3.3 | 帕妥珠单抗注射液 · No verified English nameCXSL2101162 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2021/06/29New drug · Class 1.4 | 20价肺炎球菌多糖结合疫苗 · No verified English nameCXSL2101161 | Jiangsu Kun Li Biopharmaceutical Co., Ltd. romanized; Xiamen Wan Tai Cang Hai Bio Technology Co., Ltd. romanized |
73 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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