YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 173 drug applications between 1 April 2021 and 7 April 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 16, covering 11 drug names.
2021/04/01 – 2021/04/07
- New acceptances this week
- 173
- Drugs with new generic filings (by drug name, de-duplicated)
- 11
- 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
173filings, 16 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 92 |
| New drug | 28 |
| Import | 24 |
| Generic | 16 |
| Unspecified | 7 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 124 |
| Therapeutic biologic | 36 |
| TCM | 9 |
| Prophylactic biologic | 4 |
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
11 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 头孢羟氨苄干混悬剂 · No verified English name | 2 | 1 | 2 |
| 2 | Olanzapine Tablets | 2 | 1 | 4 |
| 3 | Dapagliflozin Tablets | 2 | 1 | 84 |
| 4 | Metoprolol Tartrate Tablets | 2 | 1 | 3 |
| 5 | Ranolazine Prolonged-Release Tablets | 2 | 1 | 3 |
| 6 | Ibrutinib Capsules | 1 | 1 | 9 |
| 7 | Rivaroxaban Tablets | 1 | 1 | 3 |
| 8 | Mycophenolate Mofetil Capsules | 1 | 1 | 4 |
| 9 | Torsemide Injection | 1 | 1 | 1 |
| 10 | Glycopyrronium Bromide and Neostigmine Metilsulfate 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
107 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Janssen-Cilag International NV | 6 | 1 | 0 |
| 2 | Bao Ding Jiu Hui Pharmaceuticals Zhi Zao Co., Ltd. romanized | 5 | 5 | 0 |
| 3 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc. | 5 | 2 | 0 |
| 4 | Fo Shan De Rui Ke Pharmaceutical Co., Ltd. romanized | 5 | 1 | 0 |
| 5 | Janssen Research & Development LLC | 4 | 2 | 0 |
| 6 | Sichuan Kelun Pharmaceutical Co., Ltd. | 4 | 1 | 0 |
| 7 | Eurofins Analytical Science Laboratories Inc. | 3 | 3 | 0 |
| 8 | Pfizer Inc | 3 | 2 | 0 |
| 9 | Tong Fang Pharma Group Co., Ltd. romanized | 3 | 2 | 0 |
| 10 | Yangtze River Pharmaceutical Group Co., Ltd | 3 | 2 | 2 |
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 |
|---|---|---|
| 2021/04/07Import · Class 3.1 | 九价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2101001 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd. |
| 2021/04/07Import · Class 3.1 | 九价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2101000 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd. |
| 2021/04/07Import · Class 3.1 | 贝伐珠单抗注射液 · No verified English nameJXSS2100023 | Roche Pharma (Schweiz) AG; Roche Diagnostics GmbH |
| 2021/04/07Import · Class 1 | SEA-CD70 · No verified English nameJXSL2101005 | BeiGene Ltd.; BeiGene(Beijing) Co. Ltd. |
| 2021/04/07Import · Class 1 | PF-06863135 · No verified English nameJXSL2101004 | Pfizer Inc; Pfizer Investment CO. Ltd. |
| 2021/04/07Import · Class 2.4 | Talazoparib胶囊 · No verified English nameJXHL2101006 | Pfizer Inc; Pfizer Investment CO. Ltd. |
| 2021/04/07Import · Class 2.4 | Talazoparib胶囊 · No verified English nameJXHL2101005 | Pfizer Inc; Pfizer Investment CO. Ltd. |
| 2021/04/07Import · Class 1 | MK-5475吸入粉雾剂 · No verified English nameJXHL2101004 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2021/04/07Import · Class 1 | MK-5475吸入粉雾剂 · No verified English nameJXHL2101003 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2021/04/07Import · Class 1 | MK-5475吸入粉雾剂 · No verified English nameJXHL2101002 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2021/04/07Generic · Class 3 | 头孢羟氨苄干混悬剂 · No verified English nameCYHS2101038 | Shanghai Jin Cheng Su Zhi Pharma Co., Ltd. romanized |
| 2021/04/07Generic · Class 3 | 头孢羟氨苄干混悬剂 · No verified English nameCYHS2101037 | Shanghai Jin Cheng Su Zhi Pharma Co., Ltd. romanized |
| 2021/04/07New drug · Class 2.3 | 芩香清解口服液 · No verified English nameCXZL2101004 | Yi Pin Hong Biopharmaceuticals Co., Ltd. romanized |
| 2021/04/07New drug · Class 1 | TWP-102注射液 · No verified English nameCXSL2101011 | Shandong Tai Ze Hui Kang Biopharmaceuticals Co., Ltd. romanized |
| 2021/04/07New drug · Class 1 | SHR-1701注射液 · No verified English nameCXSL2101010 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2021/04/07New drug · Class 1 | SYSA1801注射液 · No verified English nameCXSL2101009 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2021/04/07New drug · Class 2.4 | 奥布替尼片 · No verified English nameCXHL2101025 | Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/04/07New drug · Class 1 | KL590586胶囊 · No verified English nameCXHL2101024 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2021/04/07New drug · Class 1 | KL590586胶囊 · No verified English nameCXHL2101023 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2021/04/07New drug · Class 1 | FCN-098胶囊 · No verified English nameCXHL2101021 | Chongqing Fu Chuang Pharmaceuticals Research Co., Ltd. romanized |
| 2021/04/07New drug · Class 1 | FCN-098胶囊 · No verified English nameCXHL2101020 | Chongqing Fu Chuang Pharmaceuticals Research Co., Ltd. romanized |
| 2021/04/07New drug · Class 1 | BPI-16350 胶囊 · No verified English nameCXHL2101019 | Bei Da Pharma Co., Ltd. romanized |
| 2021/04/07New drug · Class 1 | BPI-16350 胶囊 · No verified English nameCXHL2101018 | Bei Da Pharma Co., Ltd. romanized |
| 2021/04/07New drug · Class 1 | SHR1459片 · No verified English nameCXHL2101017 | Rui Shi Biopharmaceuticals Co., Ltd. romanized |
| 2021/04/07New drug · Class 1 | CK21脂肪乳注射液 · No verified English nameCXHL2100219 | Xin Kai Pharmaceuticals Chemical Zhong Jian Ti (Shanghai) Co., Ltd. romanized |
| 2021/04/03New drug · Class 1.1 | 六合丹软膏 · No verified English nameCXZL2100003 | Sichuan University Hua Xi Hospital romanized |
| 2021/04/03New drug · Class 1 | 注射用重组人源化抗Muc1单抗-Tub201偶联剂 · No verified English nameCXSL2100114 | Hangzhou Duo Xi Bio Technology Co., Ltd. romanized |
| 2021/04/03New drug · Class 3.3 | 流感病毒裂解疫苗 · No verified English nameCXSL2100113 | Shanxi Pei Sen Bio Technology Co., Ltd. romanized |
| 2021/04/03New drug · Class 2.2 | 阿地溴铵吸入粉雾剂 · No verified English nameCXHL2100218 | Health Yuan Pharma Group Co., Ltd. romanized |
| 2021/04/02Import · Class 3.3 | 注射用英夫利西单抗 · No verified English nameJXSS2100022 | CELLTRION Inc. |
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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