YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 131 drug applications between 18 June 2021 and 24 June 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 20, covering 14 drug names.
2021/06/18 – 2021/06/24
- New acceptances this week
- 131
- Drugs with new generic filings (by drug name, de-duplicated)
- 14
- 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
131filings, 20 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 73 |
| New drug | 22 |
| Generic | 20 |
| Import | 13 |
| Import re-registration | 2 |
| Unspecified | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 96 |
| Therapeutic biologic | 25 |
| TCM | 9 |
| 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
14 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Celecoxib Capsules | 4 | 1 | 5 |
| 2 | Pregabalin Capsules | 2 | 1 | 12 |
| 3 | Esomeprazole Sodium for Injection | 2 | 1 | 1 |
| 4 | Valsartan Film-Coated Tablets | 2 | 1 | 0 |
| 5 | Ornidazole Injection | 1 | 1 | 0 |
| 6 | Formoterol Fumarate Inhalation Solution | 1 | 1 | 5 |
| 7 | Tofacitinib Citrate Tablets | 1 | 1 | 1 |
| 8 | 泊沙康唑注射液 · No verified English name | 1 | 1 | 1 |
| 9 | Metformin Hydrochloride Extended-release Tablets | 1 | 1 | 10 |
| 10 | Nifedipine Extended-Release Tablets | 1 | 1 | 0 |
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
80 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | The Wellcome Foundation Limited | 7 | 2 | 0 |
| 2 | Qilu Pharmaceutical Co., Ltd. | 5 | 3 | 0 |
| 3 | IPSEN PHARMA | 5 | 1 | 0 |
| 4 | Haerbin Han Bang Medical Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 5 | Hangzhou Sen Ze Pharmaceuticals Technology Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Yi Ling Wan Zhou International Pharmaceutical Co., Ltd. romanized | 4 | 1 | 4 |
| 7 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 3 | 3 | 3 |
| 8 | Janssen Research & Development LLC | 3 | 1 | 0 |
| 9 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized | 3 | 1 | 0 |
| 10 | Anhui Yu Heng Bio Technology Co., Ltd. romanized | 3 | 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
38 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/06/22Import · Class 2.2 | 奥妥珠单抗注射液 · No verified English nameJXSL2101044 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2021/06/22Import · Class 2.2 | 注射用enfortumab vedotin · No verified English nameJXSL2101043 | Astellas Pharma US Inc.; Astellas Pharma China Inc. |
| 2021/06/22Import · Class 2.2 | 注射用enfortumab vedotin · No verified English nameJXSL2101042 | Astellas Pharma US Inc.; Astellas Pharma China Inc. |
| 2021/06/22Generic · Class 3 | Aripiprazole Oral SolutionCYHS2101331 | Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized |
| 2021/06/22Generic · Class 3 | Formoterol Fumarate Inhalation SolutionCYHS2101307 | Jinan Jing Sheng Technology Co., Ltd. romanized; Wei Fang Zhong Shi Pharmaceutical Co., Ltd. romanized |
| 2021/06/22New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2101150 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/06/22New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2101149 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/06/22New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2101148 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/06/22New drug · Class 1 | 注射用重组人FGF21-Fc融合蛋白 · No verified English nameCXSL2101145 | An Yuan Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2021/06/22New drug · Class 1 | YK-2168注射液 · No verified English nameCXHL2101218 | Nanjing Da Mei Biopharmaceutical Co., Ltd. romanized |
| 2021/06/22New drug · Class 1 | YK-2168注射液 · No verified English nameCXHL2101217 | Nanjing Da Mei Biopharmaceutical Co., Ltd. romanized |
| 2021/06/22New drug · Class 2.2 | HLK-6002软膏 · No verified English nameCXHL2101213 | Shenzhen Shi Yao Xin Bio Technology Co., Ltd. romanized |
| 2021/06/22New drug · Class 2.2 | HLK-6002软膏 · No verified English nameCXHL2101212 | Shenzhen Shi Yao Xin Bio Technology Co., Ltd. romanized |
| 2021/06/22New drug · Class 2.2 | HLK-6002软膏 · No verified English nameCXHL2101211 | Shenzhen Shi Yao Xin Bio Technology Co., Ltd. romanized |
| 2021/06/21Import · Class 1 | Palovarotene胶囊 · No verified English nameJXHL2101099 | IPSEN PHARMA; IPSEN(SHANGHAI)INNOVATION PHARMACEUTICAL CO. LTD. |
| 2021/06/21Import · Class 1 | Palovarotene胶囊 · No verified English nameJXHL2101098 | IPSEN PHARMA; IPSEN(SHANGHAI)INNOVATION PHARMACEUTICAL CO. LTD. |
| 2021/06/21Import · Class 1 | Palovarotene胶囊 · No verified English nameJXHL2101097 | IPSEN PHARMA; IPSEN(SHANGHAI)INNOVATION PHARMACEUTICAL CO. LTD. |
| 2021/06/21Import · Class 1 | Palovarotene胶囊 · No verified English nameJXHL2101096 | IPSEN PHARMA; IPSEN(SHANGHAI)INNOVATION PHARMACEUTICAL CO. LTD. |
| 2021/06/21Import · Class 1 | Palovarotene胶囊 · No verified English nameJXHL2101095 | IPSEN PHARMA; IPSEN(SHANGHAI)INNOVATION PHARMACEUTICAL CO. LTD. |
| 2021/06/21Import · Class 1 | Afuresertib片 · No verified English nameJXHL2101094 | Laekna Limited; Laekna Therapeutics Shanghai Co. Ltd. |
| 2021/06/21Import · Class 1 | Afuresertib片 · No verified English nameJXHL2101093 | Laekna Limited; Laekna Therapeutics Shanghai Co. Ltd. |
| 2021/06/21Import · Class 1 | Etrasimod片 · No verified English nameJXHL2101082 | Arena Pharmaceuticals Inc.; Everest Medicines (China) Co. Ltd |
| 2021/06/21Import · Class 1 | Etrasimod片 · No verified English nameJXHL2101081 | Arena Pharmaceuticals Inc.; Everest Medicines (China) Co. Ltd |
| 2021/06/21Generic · Class 3 | Ornidazole InjectionCYHS2101322 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Tong Hua Jin Ma Pharma Group Co., Ltd. romanized |
| 2021/06/21New drug · Class 1 | QX004N注射液 · No verified English nameCXSL2101142 | Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized |
| 2021/06/21New drug · Class 1 | BDB-001注射液 · No verified English nameCXSL2101141 | Shu Tai Shen (Beijing) Biopharmaceutical Co., Ltd. romanized; Beijing De Feng Rui Bio Technology Co., Ltd. romanized |
| 2021/06/21New drug · Class 2.4 | 环泊酚注射液 · No verified English nameCXHS2101025 | Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2021/06/21New drug · Class 1 | OB756片 · No verified English nameCXHL2101216 | Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized |
| 2021/06/21New drug · Class 1 | EN002凝胶 · No verified English nameCXHL2101215 | En Kang Pharma Technology (Guangzhou) Co., Ltd. romanized |
| 2021/06/21New drug · Class 1 | EN002凝胶 · No verified English nameCXHL2101214 | En Kang Pharma Technology (Guangzhou) Co., Ltd. romanized |
8 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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