YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 208 drug applications between 19 March 2021 and 25 March 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 11, covering 8 drug names.
2021/03/19 – 2021/03/25
- New acceptances this week
- 208
- Drugs with new generic filings (by drug name, de-duplicated)
- 8
- 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
208filings, 11 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 112 |
| Import | 34 |
| New drug | 31 |
| Generic | 11 |
| Unspecified | 10 |
| Import re-registration | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 158 |
| Therapeutic biologic | 41 |
| Prophylactic biologic | 5 |
| TCM | 2 |
| In vitro diagnostic reagent | 1 |
| 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
8 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Argatroban Injection | 2 | 2 | 2 |
| 2 | Saxagliptin Tablets | 2 | 1 | 0 |
| 3 | 酒石酸伐尼克兰片 · No verified English name | 2 | 1 | 3 |
| 4 | 头孢地尼颗粒 · No verified English name | 1 | 1 | 3 |
| 5 | 特利加压素注射液 · No verified English name | 1 | 1 | 0 |
| 6 | Venlafaxine Hydrochloride Sustained-Release Capsules | 1 | 1 | 0 |
| 7 | Lanthanum Carbonate Chewable Tablets | 1 | 1 | 2 |
| 8 | Sitagliptin Phosphate Tablets | 1 | 1 | 2 |
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
109 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Beijing Si Huan Biopharmaceutical Co., Ltd. romanized | 10 | 1 | 0 |
| 2 | Sichuan Kelun Pharmaceutical Co., Ltd. | 7 | 3 | 0 |
| 3 | AstraZeneca UK Limited | 6 | 2 | 0 |
| 4 | Astrazeneca UK Limited | 6 | 1 | 0 |
| 5 | Kyowa Kirin Co. Ltd. | 6 | 1 | 0 |
| 6 | LABORATORIOS FARMACEUTICOS ROVI S.A. | 5 | 1 | 0 |
| 7 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 4 | 3 | 0 |
| 8 | Loxo Oncology Inc. | 4 | 1 | 0 |
| 9 | Merck Europe B.V. | 4 | 1 | 0 |
| 10 | Mirum Pharmaceuticals Inc. | 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
55 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/03/25Import · Class 1 | Tiragolumab注射液 · No verified English nameJXSL2100042 | F.Hoffmann-La Roche Ltd |
| 2021/03/25Import · Class 1 | SEP-363856片 · No verified English nameJXHL2100108 | Sunovion Pharmaceuticals Inc. |
| 2021/03/25Import · Class 1 | SEP-363856片 · No verified English nameJXHL2100107 | Sunovion Pharmaceuticals Inc. |
| 2021/03/25Import · Class 1 | SEP-363856片 · No verified English nameJXHL2100106 | Sunovion Pharmaceuticals Inc. |
| 2021/03/25Import · Class 1 | SEP-363856片 · No verified English nameJXHL2100105 | Sunovion Pharmaceuticals Inc. |
| 2021/03/25Generic · Class 3 | 特利加压素注射液 · No verified English nameCYHS2100290 | Shenzhen Shi Jian Xiang Biopharmaceutical Co., Ltd. romanized |
| 2021/03/25New drug · Class 3.3 | 贝伐珠单抗注射液 · No verified English nameCXSL2100105 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2021/03/25New drug · Class 3.3 | 贝伐珠单抗注射液 · No verified English nameCXSL2100104 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2021/03/25New drug · Class 1 | AK117注射液 · No verified English nameCXSL2100103 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2021/03/25New drug · Class 1 | 二甲苯磺酸萘普替尼片 · No verified English nameCXHL2100203 | Shenzhen Hai Wang Pharmaceuticals Technology Research Institute Co., Ltd. romanized |
| 2021/03/24Import · Class 1 | 巴替利单抗注射液 · No verified English nameJXSL2100044 | Agenus Inc. |
| 2021/03/24Import · Class 1 | TransCon PTH注射液 · No verified English nameJXHL2100104 | Ascendis Pharma Bone Diseases A/S |
| 2021/03/24Import · Class 1 | TransCon PTH注射液 · No verified English nameJXHL2100103 | Ascendis Pharma Bone Diseases A/S |
| 2021/03/24Import · Class 1 | TransCon PTH注射液 · No verified English nameJXHL2100102 | Ascendis Pharma Bone Diseases A/S |
| 2021/03/24Import · Class 1 | Linerixibat片 · No verified English nameJXHL2100101 | GlaxoSmithKline (Ireland) Limited |
| 2021/03/24New drug · Class 2.3 | 馥感啉口服液 · No verified English nameCXZL2101001 | Yi Pin Hong Biopharmaceuticals Co., Ltd. romanized |
| 2021/03/24New drug · Class 1 | GZR18 · No verified English nameCXSL2100100 | Gan Li Pharma Co., Ltd. romanized |
| 2021/03/24New drug · Class 1 | GZR18 · No verified English nameCXSL2100099 | Gan Li Pharma Co., Ltd. romanized |
| 2021/03/24New drug · Class 1 | JAB-21822片 · No verified English nameCXHL2101006 | Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized |
| 2021/03/24New drug · Class 1 | JAB-21822片 · No verified English nameCXHL2101005 | Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized |
| 2021/03/24New drug · Class 2.2 | 枸橼酸西地那非口溶膜 · No verified English nameCXHL2100202 | Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2021/03/24New drug · Class 2.2 | 枸橼酸西地那非口溶膜 · No verified English nameCXHL2100201 | Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2021/03/24New drug · Class 1 | FWD1509 MsOH片 · No verified English nameCXHL2100200 | Shenzhen Fu Wo Pharma Co., Ltd. romanized |
| 2021/03/24New drug · Class 1 | FWD1509 MsOH片 · No verified English nameCXHL2100199 | Shenzhen Fu Wo Pharma Co., Ltd. romanized |
| 2021/03/24New drug · Class 1 | FWD1509 MsOH片 · No verified English nameCXHL2100198 | Shenzhen Fu Wo Pharma Co., Ltd. romanized |
| 2021/03/23Import · Class 1 | 注射用LNA043 · No verified English nameJXSL2100043 | Novartis Pharma AG |
| 2021/03/23Generic · Class 3 | 头孢地尼颗粒 · No verified English nameCYHS2100289 | Hefei En Rui Te Pharma Co., Ltd. romanized; Anhui An Ke Heng Yi Pharma Co., Ltd. romanized |
| 2021/03/23New drug · Class 3.3 | 重组人GLP-1-Fc融合蛋白注射液 · No verified English nameCXSL2100102 | Hua Run Ang De Bio Pharma Co., Ltd. romanized |
| 2021/03/23New drug · Class 3.3 | 重组人GLP-1-Fc融合蛋白注射液 · No verified English nameCXSL2100101 | Hua Run Ang De Bio Pharma Co., Ltd. romanized |
| 2021/03/23New drug · Class 1 | 西格列他钠片 · No verified English nameCXHL2101009 | Chengdu Wei Xin Pharma Co., Ltd. romanized |
25 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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