YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 279 drug applications between 26 December 2021 and 1 January 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 68, covering 46 drug names.
2021/12/26 – 2022/01/01
- New acceptances this week
- 279
- Drugs with new generic filings (by drug name, de-duplicated)
- 46
- 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
279filings, 68 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 110 |
| New drug | 72 |
| Generic | 68 |
| Import | 13 |
| Import re-registration | 8 |
| Unspecified | 7 |
| Drug-device combination product | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 208 |
| Therapeutic biologic | 48 |
| TCM | 18 |
| Biologic | 2 |
| Prophylactic biologic | 2 |
| Drug-device combination | 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
46 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Tranexamic Acid Injection | 3 | 2 | 11 |
| 2 | Venlafaxine Hydrochloride Sustained-Release Capsules | 3 | 2 | 0 |
| 3 | Sildenafil Citrate Tablets | 3 | 1 | 12 |
| 4 | Losartan Potassium and Hydrochlorothiazide Tablets | 3 | 1 | 1 |
| 5 | 阿普米司特片 · No verified English name | 3 | 1 | 3 |
| 6 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 7 | Olanzapine Orally Disintegrating Tablets | 2 | 1 | 0 |
| 8 | Ticagrelor Tablets | 2 | 1 | 10 |
| 9 | Sacubitril Valsartan Sodium Tablets | 2 | 1 | 70 |
| 10 | 注射用盐酸头孢吡肟/氯化钠注射液 · No verified English name | 2 | 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
165 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hua Run Shuang He Pharma Co., Ltd. romanized | 7 | 5 | 3 |
| 2 | Yang Zi Jiang Pharma Group Jiangsu Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 3 | Zhejiang Nord Pharmaceutical Co., Ltd | 6 | 3 | 6 |
| 4 | Shandong Run Ze Pharmaceutical Co., Ltd. romanized | 6 | 1 | 0 |
| 5 | Guangdong Ke Lun Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 6 | Guangzhou Run Er Yan Ke Bio Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 4 | 4 | 3 |
| 8 | Shanghai Xu Dong Hai Pu Pharma Co., Ltd. romanized | 4 | 3 | 2 |
| 9 | AstraZeneca AB | 4 | 2 | 0 |
| 10 | Beijing Rui Ye Pharmaceutical Co., Ltd. romanized | 4 | 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
100 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/12/31Generic · Class 3 | Dobutamine Hydrochloride InjectionCYHS2102338 | Shanghai Xu Dong Hai Pu Pharma Co., Ltd. romanized |
| 2021/12/31Generic · Class 3 | Dobutamine Hydrochloride InjectionCYHS2102337 | Shanghai Xu Dong Hai Pu Pharma Co., Ltd. romanized |
| 2021/12/31Generic · Class 3 | Digoxin InjectionCYHS2102336 | Zhong Run Pharma Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2021/12/31Generic · Class 3 | Ambroxol Hydrochloride Oral SolutionCYHS2102335 | Heilongjiang Zhen Bao Dao Pharma Co., Ltd. romanized |
| 2021/12/31Generic · Class 3 | Flurbiprofen Axetil InjectionCYHL2101059 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2021/12/31New drug · Class 2.4 | 注射用重组A型肉毒毒素 · No verified English nameCXSL2101534 | Chongqing Yu Yan Pharmaceutical Co., Ltd. romanized |
| 2021/12/31New drug · Class 1 | GC304腺相关病毒注射液 · No verified English nameCXSL2101532 | Beijing Jin Lan Ji Yin Technology Co., Ltd. romanized |
| 2021/12/31New drug · Class 1 | 靶向HLA-A*02:01/NY-ESO-1的TCR-T细胞注射液 · No verified English nameCXSL2101531 | Shenzhen Pu Rui Jin Bio Pharma Co., Ltd. romanized |
| 2021/12/31New drug · Class 1 | 靶向Survivin DC细胞注射液 · No verified English nameCXSL2101530 | Qi Chen Sheng Bio Technology (Zhuhai) Co., Ltd. romanized |
| 2021/12/31New drug · Class 1 | JMKX000623片 · No verified English nameCXHL2101856 | Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/12/31New drug · Class 1 | JMKX000623片 · No verified English nameCXHL2101855 | Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/12/31New drug · Class 2.2; 2.4 | 孟鲁司特钠凝胶 · No verified English nameCXHL2101854 | Jiang Yin Bei Rui Sen Pharmaceutical Co., Ltd. romanized |
| 2021/12/31New drug · Class 2.2 | 孟鲁司特钠凝胶 · No verified English nameCXHL2101853 | Jiang Yin Bei Rui Sen Pharmaceutical Co., Ltd. romanized |
| 2021/12/31New drug · Class 1 | KL130008胶囊 · No verified English nameCXHL2101852 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2021/12/31New drug · Class 1 | KL130008胶囊 · No verified English nameCXHL2101851 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2021/12/31New drug · Class 1 | KL130008胶囊 · No verified English nameCXHL2101850 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2021/12/31New drug · Class 2.2 | BCM235缓释干混悬剂 · No verified English nameCXHL2101825 | Shanghai Bo Zhi Yan Xin Drug Technology Co., Ltd. romanized |
| 2021/12/30Import · Class 3.1 | 注射用维博妥珠单抗 · No verified English nameJXSS2101037 | Roche Pharma (Schweiz)AG; F. Hoffmann-La Roche AG |
| 2021/12/30Import · Class 3.1 | 注射用维博妥珠单抗 · No verified English nameJXSS2101036 | Roche Pharma (Schweiz)AG; BSP Pharmaceuticals S.p.A. |
| 2021/12/30Import · Class 1 | Sepantronium Bromide注射液 · No verified English nameJXHL2101289 | Cothera Bioscience Inc.; Beijing Percans Oncology Co. Ltd. |
| 2021/12/30Generic · Class 3 | Thioctic Acid TabletsCYHS2102326 | Ya Bao Pharma Group Co., Ltd. romanized |
| 2021/12/30Generic · Class 3 | Thioctic Acid TabletsCYHS2102325 | Ya Bao Pharma Group Co., Ltd. romanized |
| 2021/12/30Generic · Class 3 | Ornidazole InjectionCYHS2102322 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2021/12/30Generic · Class 3 | 注射用盐酸头孢吡肟/氯化钠注射液 · No verified English nameCYHS2102321 | Beijing Rui Ye Pharmaceutical Co., Ltd. romanized |
| 2021/12/30Generic · Class 3 | 注射用盐酸头孢吡肟/氯化钠注射液 · No verified English nameCYHS2102318 | Beijing Rui Ye Pharmaceutical Co., Ltd. romanized |
| 2021/12/30Generic · Class 3 | Tranexamic Acid InjectionCYHS2102317 | Jin Zhou Ao Hong Pharma Co., Ltd. romanized |
| 2021/12/30Generic · Class 3 | Tranexamic Acid InjectionCYHS2102316 | Jin Zhou Ao Hong Pharma Co., Ltd. romanized |
| 2021/12/30New drug · Class 1.1 | 秦苓颗粒 · No verified English nameCXZL2101043 | Beijing Niu Wei Po Ao Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/12/30New drug · Class 1.1 | 驹藿片 · No verified English nameCXZL2101042 | Beijing Niu Wei Po Ao Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/12/30New drug · Class 1.1 | 牛贝消核颗粒 · No verified English nameCXZL2101041 | Guangdong Qi Fang Pharma Co., Ltd. romanized |
70 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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