YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 426 drug applications between 14 December 2021 and 20 December 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 51, covering 36 drug names.
2021/12/14 – 2021/12/20
- New acceptances this week
- 426
- Drugs with new generic filings (by drug name, de-duplicated)
- 36
- 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
426filings, 51 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 251 |
| New drug | 89 |
| Generic | 51 |
| Import | 13 |
| Import re-registration | 12 |
| Unspecified | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 311 |
| TCM | 60 |
| Therapeutic biologic | 50 |
| Prophylactic biologic | 5 |
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
36 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Guanfacine Hydrochloride Extended Release Tablets | 4 | 1 | 4 |
| 2 | Sodium Hyaluronate Eye Drops | 3 | 2 | 30 |
| 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English name | 3 | 1 | 2 |
| 4 | Ambroxol Hydrochloride Solution For Inhalation | 2 | 2 | 10 |
| 5 | 地氯雷他定口服溶液 · No verified English name | 2 | 2 | 26 |
| 6 | Vildagliptin Tablets | 2 | 2 | 0 |
| 7 | Nintedanib Esilate Soft Capsules | 2 | 1 | 6 |
| 8 | Eplerenone Tablets | 2 | 1 | 4 |
| 9 | Ipratropium Bromide Inhalation Solution | 2 | 1 | 2 |
| 10 | Sildenafil Citrate Tablets | 2 | 1 | 12 |
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
187 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hua Run Shuang He Pharma Co., Ltd. romanized | 66 | 56 | 0 |
| 2 | Jilin Sheng Shen Lu Pharmaceutical Co., Ltd. romanized | 32 | 25 | 0 |
| 3 | Zhengzhou Yu Gang Zhi Xing Pharmaceutical Co., Ltd. romanized | 10 | 9 | 0 |
| 4 | Haerbin Tian Mei Pharma Co., Ltd. romanized | 10 | 6 | 0 |
| 5 | Guizhou Liang Ji Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | Heilongjiang Kui Hua Pharma Co., Ltd. romanized | 6 | 5 | 0 |
| 7 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 6 | 3 | 0 |
| 8 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 6 | 2 | 4 |
| 9 | Janssen-Cilag International NV | 6 | 1 | 0 |
| 10 | Eli Lilly and Company | 5 | 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
120 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/12/20Import · Class 1 | Ritlecitinib胶囊 · No verified English nameJXHL2101275 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2021/12/20Import · Class 1 | Ritlecitinib胶囊 · No verified English nameJXHL2101274 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2021/12/20Generic · Class 3 | 注射用头孢美唑钠/氯化钠注射液 · No verified English nameCYHS2102231 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2021/12/20Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2102216 | Anhui Xin Shi Ji Pharma Co., Ltd. romanized |
| 2021/12/20Generic · Class 3 | Acetazolamide Extended-release CapsulesCYHL2101056 | Henan Zhong Shuai Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/12/20New drug · Class 1 | 注射用重组变构人肿瘤坏死因子相关凋亡诱导配体 · No verified English nameCXSS2101065 | Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized |
| 2021/12/20New drug · Class 1 | PM8002注射液 · No verified English nameCXSL2101495 | Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized |
| 2021/12/20New drug · Class 1 | SHR-1316注射液 · No verified English nameCXSL2101493 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2021/12/20New drug · Class 1 | 注射用SHR-A1811 · No verified English nameCXSL2101492 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2021/12/20New drug · Class 1 | HBW-3220胶囊 · No verified English nameCXHL2101795 | Chengdu Hai Bo Wei Pharma Co., Ltd. romanized |
| 2021/12/20New drug · Class 1 | HMPL-689胶囊 · No verified English nameCXHL2101794 | He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2021/12/20New drug · Class 1 | HMPL-689胶囊 · No verified English nameCXHL2101793 | He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2021/12/20New drug · Class 2.4 | Pyrotinib Maleate TabletsCXHL2101792 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/12/20New drug · Class 2.4 | Pyrotinib Maleate TabletsCXHL2101791 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/12/20New drug · Class 1 | SHR0302片 · No verified English nameCXHL2101790 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/12/20New drug · Class 1 | SHR0302片 · No verified English nameCXHL2101789 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/12/20New drug · Class 1 | SHR0302片 · No verified English nameCXHL2101788 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/12/20New drug · Class 1 | IMP9064片 · No verified English nameCXHL2101780 | Shanghai Ying Pai Pharma Co., Ltd. romanized |
| 2021/12/20New drug · Class 1 | IMP9064片 · No verified English nameCXHL2101779 | Shanghai Ying Pai Pharma Co., Ltd. romanized |
| 2021/12/17Import · Class 1 | 注射用TNP-2092 · No verified English nameJXHL2101269 | TenNor Therapeutics Limited; TenNor (Suzhou) Therapeutics Limited |
| 2021/12/17Generic · Class 3 | Methotrexate For InjectionCYHS2102209 | Shanghai Shang Yao Rui Er Medicines Co., Ltd. romanized; Shanghai Pharmaceuticals Group (Ben Xi) Bei Fang Pharma Co., Ltd. romanized |
| 2021/12/17Generic · Class 3 | Eplerenone TabletsCYHS2102151 | Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized; Jiangsu Yun Yang Group Pharma Co., Ltd. romanized |
| 2021/12/17Generic · Class 3 | Eplerenone TabletsCYHS2102150 | Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized; Jiangsu Yun Yang Group Pharma Co., Ltd. romanized |
| 2021/12/17New drug · Class 1 | 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液 · No verified English nameCXSL2101491 | Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized |
| 2021/12/17New drug · Class 1 | 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液 · No verified English nameCXSL2101490 | Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized |
| 2021/12/17New drug · Class 1 | 人iPSC来源心肌细胞注射液 · No verified English nameCXSL2101489 | Nanjing Ai Er Pu Zai Sheng Yi Xue Technology Co., Ltd. romanized |
| 2021/12/17New drug · Class 1 | 重组抗HER2结构域Ⅱ和结构域Ⅳ双特异性抗体注射液 · No verified English nameCXSL2101488 | Xuan Zhu Bio Technology Co., Ltd. romanized; Beijing Xuan Zhu Kang Ming Bio Technology Co., Ltd. romanized |
| 2021/12/17New drug · Class 1 | YH001注射液 · No verified English nameCXSL2101481 | Name not romanized |
| 2021/12/17New drug · Class 2.4 | 甲磺酸伏美替尼片 · No verified English nameCXHS2101055 | Shanghai Ai Li Si Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Ai Li Si Biopharmaceuticals Co., Ltd. romanized |
| 2021/12/17New drug · Class 1 | ABSK061胶囊 · No verified English nameCXHL2101785 | Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized |
90 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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