YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 223 drug applications between 20 January 2021 and 26 January 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 36, covering 28 drug names.
2021/01/20 – 2021/01/26
- New acceptances this week
- 223
- Drugs with new generic filings (by drug name, de-duplicated)
- 28
- 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
223filings, 36 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 109 |
| Generic | 36 |
| New drug | 31 |
| Import | 27 |
| Import re-registration | 11 |
| Unspecified | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 176 |
| Therapeutic biologic | 30 |
| TCM | 10 |
| Prophylactic biologic | 4 |
| In vitro diagnostic reagent | 2 |
| 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
28 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Delafloxacin for Injection | 2 | 2 | 0 |
| 2 | ω-3鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(36%)注射液 · No verified English name | 2 | 1 | 0 |
| 3 | Sodium Valproate Concentrated Solution for Injection | 2 | 1 | 0 |
| 4 | Canagliflozin Tablets | 2 | 1 | 8 |
| 5 | Levocarnitine Injection | 2 | 1 | 4 |
| 6 | Temozolomide Capsules | 2 | 1 | 0 |
| 7 | Cisatracurium Besylate Injection | 2 | 1 | 4 |
| 8 | Febuxostat Tablets | 2 | 1 | 12 |
| 9 | 依托咪酯乳状注射液 · No verified English name | 1 | 1 | 1 |
| 10 | Linezolid and Glucose Injection | 1 | 1 | 3 |
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
134 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | AstraZeneca AB | 7 | 2 | 0 |
| 2 | Pfizer Europe MA EEIG | 6 | 3 | 0 |
| 3 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 0 |
| 4 | Changzhou Heng Bang Pharma Co., Ltd. romanized | 4 | 3 | 0 |
| 5 | Qilu Pharmaceutical Co., Ltd. | 4 | 3 | 1 |
| 6 | Shandong Run Ze Pharmaceutical Co., Ltd. romanized | 4 | 2 | 0 |
| 7 | Luo Shi Research and Development (Zhongguo) Co., Ltd. romanized | 4 | 2 | 0 |
| 8 | Suzhou Xi Ke Luo Pharmaceutical Co., Ltd. romanized | 4 | 1 | 0 |
| 9 | Yangtze River Pharmaceutical Group Co., Ltd | 3 | 3 | 3 |
| 10 | Dr. Reddy's Laboratories Limited | 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
58 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/01/25Import · Class 2.2 | DS-8201a · No verified English nameJXSL2100011 | Daiichi Sankyo Inc. |
| 2021/01/25Import · Class 1 | Faricimab注射液 · No verified English nameJXSL2100010 | F. Hoffmann-La Roche Ltd |
| 2021/01/25Import · Class 2.2 | JKB-122胶囊 · No verified English nameJXHL2100028 | Unspecified |
| 2021/01/25Import · Class 2.2; 2.4 | JKB-122胶囊 · No verified English nameJXHL2100027 | Unspecified |
| 2021/01/25Generic · Class 3 | 吸入用氯化乙酰甲胆碱粉末 · No verified English nameCYHS2100110 | Beijing Tai De Pharmaceutical Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2021/01/25Generic · Class 3 | Delafloxacin for InjectionCYHL2100006 | Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized |
| 2021/01/25Generic · Class 3 | 立他司特滴眼液 · No verified English nameCYHL2100005 | Chengdu Kang Hong Pharma Group Co., Ltd. romanized |
| 2021/01/25New drug · Class 2.2 | 康柏西普眼用注射液 · No verified English nameCXSS2100012 | Chengdu Kang Hong Bio Technology Co., Ltd. romanized |
| 2021/01/25New drug · Class 1 | AK120注射液 · No verified English nameCXSL2100014 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2021/01/23Import · Class 2.4 | Dapagliflozin TabletsJXHS2100010 | AstraZeneca AB; AstraZeneca Pharmaceuticals LP |
| 2021/01/23Import · Class 2.4 | Dapagliflozin TabletsJXHS2100009 | AstraZeneca AB; AstraZeneca Pharmaceuticals LP |
| 2021/01/23Import · Class 2.2; 2.4 | 硫酸阿托品滴眼液 · No verified English nameJXHL2100026 | Santen Pharmaceutical Co. Ltd. |
| 2021/01/23Import · Class 2.2 | 硫酸阿托品滴眼液 · No verified English nameJXHL2100025 | Santen Pharmaceutical Co. Ltd. |
| 2021/01/23Import · Class 2.2; 2.4 | 硫酸阿托品滴眼液 · No verified English nameJXHL2100024 | Santen Pharmaceutical Co. Ltd. |
| 2021/01/23Generic · Class 3 | Sodium Valproate Concentrated Solution for InjectionCYHS2100101 | Chengdu Li Er Pharma Co., Ltd. romanized |
| 2021/01/23Generic · Class 3 | Sodium Valproate Concentrated Solution for InjectionCYHS2100100 | Chengdu Li Er Pharma Co., Ltd. romanized |
| 2021/01/23Generic · Class 3 | Delafloxacin for InjectionCYHL2100004 | Yangtze River Pharmaceutical Group Co., Ltd |
| 2021/01/23New drug · Class 1 | IBI318 · No verified English nameCXSL2100029 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2021/01/23New drug · Class 1 | 盐酸依地西汀片 · No verified English nameCXHL2100055 | Suzhou Xi Ke Luo Pharmaceutical Co., Ltd. romanized |
| 2021/01/23New drug · Class 1 | 盐酸依地西汀片 · No verified English nameCXHL2100054 | Suzhou Xi Ke Luo Pharmaceutical Co., Ltd. romanized |
| 2021/01/23New drug · Class 1 | 盐酸依地西汀片 · No verified English nameCXHL2100053 | Suzhou Xi Ke Luo Pharmaceutical Co., Ltd. romanized |
| 2021/01/23New drug · Class 1 | 盐酸依地西汀片 · No verified English nameCXHL2100052 | Suzhou Xi Ke Luo Pharmaceutical Co., Ltd. romanized |
| 2021/01/23New drug · Class 1 | HSK29116散 · No verified English nameCXHL2100051 | Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2021/01/23New drug · Class 1 | HSK29116散 · No verified English nameCXHL2100050 | Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2021/01/23New drug · Class 1 | HSK29116散 · No verified English nameCXHL2100049 | Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2021/01/22Generic · Class 3 | ω-3鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(36%)注射液 · No verified English nameCYHS2100094 | Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2021/01/22Generic · Class 3 | ω-3鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(36%)注射液 · No verified English nameCYHS2100093 | Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2021/01/22New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2100028 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/01/22New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2100027 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/01/22New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2100026 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
28 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.