YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 301 drug applications between 21 April 2021 and 27 April 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 39, covering 29 drug names.
2021/04/21 – 2021/04/27
- New acceptances this week
- 301
- Drugs with new generic filings (by drug name, de-duplicated)
- 29
- 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
301filings, 39 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 137 |
| New drug | 68 |
| Generic | 39 |
| Import | 28 |
| Import re-registration | 19 |
| Unspecified | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 209 |
| TCM | 47 |
| Therapeutic biologic | 44 |
| 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
29 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Tadalafil Tablets | 4 | 1 | 23 |
| 2 | Rivaroxaban Tablets | 3 | 2 | 3 |
| 3 | Ornidazole Injection | 2 | 1 | 0 |
| 4 | Obeticholic Acid Tablets | 2 | 1 | 0 |
| 5 | Ticagrelor Tablets | 2 | 1 | 10 |
| 6 | Vitamin K1 Injection | 2 | 1 | 6 |
| 7 | Cabozantinib Tablets | 2 | 1 | 0 |
| 8 | Sodium Valproate Concentrated Solution for Injection | 1 | 1 | 0 |
| 9 | Risperidone Oral Solution | 1 | 1 | 6 |
| 10 | Doxofylline Injection | 1 | 1 | 5 |
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
167 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Nei Menggu Meng He Pharmaceutical Co., Ltd. romanized | 25 | 25 | 0 |
| 2 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 8 | 4 | 0 |
| 3 | Lilly France | 8 | 2 | 0 |
| 4 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 6 | 3 | 0 |
| 5 | AstraZeneca AB | 6 | 1 | 0 |
| 6 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 5 | 3 | 0 |
| 7 | Novartis Pharma Schweiz AG | 5 | 2 | 0 |
| 8 | Sichuan Kelun Pharmaceutical Co., Ltd. | 5 | 2 | 0 |
| 9 | Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Yan Tai Yuan Sheng Pharma Co., Ltd. romanized | 4 | 3 | 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
98 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/04/27Import · Class 1 | Cetrelimab · No verified English nameJXSL2101017 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2021/04/27Import · Class 1 | 泽弗利单抗注射液 · No verified English nameJXSL2101015 | Agenus Inc.; Betta Pharmaceuticals Co. Ltd. |
| 2021/04/27Import · Class 2.2 | TAR-200 · No verified English nameJXHL2101020 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2021/04/27Import · Class 2.4 | Selpercatinib胶囊 · No verified English nameJXHL2101019 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2021/04/27Import · Class 2.4 | Selpercatinib胶囊 · No verified English nameJXHL2101018 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2021/04/27Generic · Class 3 | Lansoprazole For InjectionCYHS2101110 | Shandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanized; Hangzhou Ao Ya Bio Technology Co., Ltd. romanized |
| 2021/04/27New drug · Class 1 | 重组人源化单克隆抗体MIL62注射液 · No verified English nameCXSL2101046 | Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized |
| 2021/04/27New drug · Class 1 | GNC-035四特异性抗体注射液 · No verified English nameCXSL2101045 | Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2021/04/27New drug · Class 1 | 重组抗IL-1β人源化单克隆抗体注射液 · No verified English nameCXSL2101043 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2021/04/27New drug · Class 1 | 重组抗IL-1β人源化单克隆抗体注射液 · No verified English nameCXSL2101042 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2021/04/27New drug · Class 1 | CAN106注射液 · No verified English nameCXSL2101041 | Nuo Ai Pharma (Shanghai) Co., Ltd. romanized |
| 2021/04/27New drug · Class 1 | EX103注射液 · No verified English nameCXSL2101037 | Guangzhou Ai Si Mai Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/04/27New drug · Class 1 | SHR6390片 · No verified English nameCXHS2101008 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/04/27New drug · Class 1 | SHR6390片 · No verified English nameCXHS2101007 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/04/27New drug · Class 1 | SHR6390片 · No verified English nameCXHS2101006 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/04/27New drug · Class 1 | SHR6508注射液 · No verified English nameCXHL2101089 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/04/27New drug · Class 2.2 | 氨酚氢可酮缓释片 · No verified English nameCXHL2101088 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2021/04/27New drug · Class 2.2 | 巯嘌呤微片 · No verified English nameCXHL2101087 | Shou Du Yi Ke University Fu Shu Beijing Er Tong Hospital romanized |
| 2021/04/27New drug · Class 2.4 | 硫酸阿托品滴眼液 · No verified English nameCXHL2101086 | Shenyang Xing Qi Yan Yao Co., Ltd. romanized |
| 2021/04/27New drug · Class 2.4 | 硫酸阿托品滴眼液 · No verified English nameCXHL2101085 | Shenyang Xing Qi Yan Yao Co., Ltd. romanized |
| 2021/04/27New drug · Class 1 | 注射用MT1013 · No verified English nameCXHL2101084 | Shaanxi Mai Ke Ao Te Technology Co., Ltd. romanized |
| 2021/04/27New drug · Class 2.4 | Apatinib Mesylate TabletsCXHL2101083 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/04/27New drug · Class 1 | YS001胶囊 · No verified English nameCXHL2101082 | Suzhou Ze Run Xin Yao Research and Development Co., Ltd. romanized |
| 2021/04/27New drug · Class 1 | TQB3811片 · No verified English nameCXHL2101081 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2021/04/27New drug · Class 1 | TQB3811片 · No verified English nameCXHL2101080 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2021/04/26Import · Class 1 | IMG-020注射液 · No verified English nameJXSL2101014 | Affibody AB; Inmagene Biopharmaceuticals (Hangzhou) Co. Ltd. |
| 2021/04/26Import · Class 2.4 | Osimertinib Mesylate TabletsJXHL2101016 | AstraZeneca AB; Astrazeneca Investment (China) Co. Ltd. |
| 2021/04/26Import · Class 2.4 | Osimertinib Mesylate TabletsJXHL2101015 | AstraZeneca AB; Astrazeneca Investment (China) Co. Ltd. |
| 2021/04/26Import · Class 1 | BBP-398 胶囊 · No verified English nameJXHL2101014 | Navire Pharma Inc.; Shanghai LianBio Development Co. Ltd. |
| 2021/04/26Import · Class 1 | BBP-398胶囊 · No verified English nameJXHL2101013 | Navire Pharma Inc.; Shanghai LianBio Development Co. Ltd. |
68 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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