YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 192 drug applications between 13 July 2021 and 19 July 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 21, covering 19 drug names.
2021/07/13 – 2021/07/19
- New acceptances this week
- 192
- Drugs with new generic filings (by drug name, de-duplicated)
- 19
- 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
192filings, 21 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 105 |
| New drug | 40 |
| Generic | 21 |
| Import | 13 |
| Unspecified | 10 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 128 |
| Therapeutic biologic | 38 |
| TCM | 21 |
| Biologic | 4 |
| 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
19 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Epinastine Hydrochloride Granules | 2 | 1 | 0 |
| 2 | Ropivacaine hydrochloride injection | 2 | 1 | 5 |
| 3 | Sodium Valproate Oral Solution | 1 | 1 | 1 |
| 4 | Rivastigmine transdermal system | 1 | 1 | 1 |
| 5 | Salbutamol Sulfate Inhalation Solution | 1 | 1 | 2 |
| 6 | Digoxin Injection | 1 | 1 | 3 |
| 7 | 奥美拉唑碳酸氢钠干混悬剂(II) · No verified English name | 1 | 1 | 0 |
| 8 | Olmesartan Medoxomil Tablets | 1 | 1 | 1 |
| 9 | Levetiracetam extended-release tablets | 1 | 1 | 0 |
| 10 | Sildenafil Citrate Tablets | 1 | 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
121 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hefei Li Fang Pharmaceutical Co., Ltd. romanized | 10 | 10 | 0 |
| 2 | Actelion Pharmaceuticals Ltd | 8 | 1 | 0 |
| 3 | Novartis Pharma Schweiz AG | 7 | 1 | 0 |
| 4 | Sichuan Yuan Da Shu Yang Pharma Co., Ltd. romanized | 6 | 2 | 0 |
| 5 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized | 5 | 3 | 5 |
| 6 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized | 4 | 1 | 0 |
| 7 | Bei Da Pharma Co., Ltd. romanized | 4 | 1 | 0 |
| 8 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 3 | 2 | 0 |
| 9 | Eli Lilly and Company | 3 | 1 | 0 |
| 10 | Loxo Oncology Inc. | 3 | 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
57 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/07/19Generic · Class 3 | Levobupivacaine Hydrochloride InjectionCYHS2101449 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2021/07/19New drug · Class 2.3 | 滋肾育胎丸 · No verified English nameCXZL2101019 | Guangzhou Bai Yun Shan Zhong Yi Pharma Co., Ltd. romanized |
| 2021/07/19New drug · Class 1 | 重组抗VEGFR2全人源单克隆抗体注射液 · No verified English nameCXSL2101203 | Beijing Dong Fang Bai Tai Bio Technology Co., Ltd. romanized |
| 2021/07/19New 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 nameCXSL2101191 | Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized |
| 2021/07/19New drug · Class 1 | 注射用RC118 · No verified English nameCXSL2101189 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2021/07/19New drug · Class 2.2 | 依达拉奉舌下片 · No verified English nameCXHS2101030 | Nanjing Bai Xin Yu Pharmaceuticals Co., Ltd. romanized; Yao Yuan Bio Technology (Qi Dong) Co., Ltd. romanized |
| 2021/07/19New drug · Class 1 | LPM3770164缓释片 · No verified English nameCXHL2101302 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2021/07/19New drug · Class 1 | LPM3770164缓释片 · No verified English nameCXHL2101301 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2021/07/19New drug · Class 1 | LPM3770164缓释片 · No verified English nameCXHL2101300 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2021/07/19New drug · Class 1 | LPM3770164缓释片 · No verified English nameCXHL2101299 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2021/07/16Import · Class 1 | LOXO-305片 · No verified English nameJXHL2101139 | Loxo Oncology Inc.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2021/07/16Import · Class 1 | LOXO-305片 · No verified English nameJXHL2101138 | Loxo Oncology Inc.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2021/07/16Import · Class 1 | LOXO-305片 · No verified English nameJXHL2101137 | Loxo Oncology Inc.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2021/07/16Import · Class 1 | Finerenone TabletsJXHL2101136 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2021/07/16Import · Class 1 | Finerenone TabletsJXHL2101135 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2021/07/16Generic · Class 3 | Tranexamic Acid InjectionCYHS2101442 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized |
| 2021/07/16New drug · Class 1 | SHR-1701注射液 · No verified English nameCXSL2101202 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2021/07/16New drug · Class 1 | 恩沃利单抗注射液 · No verified English nameCXSL2101201 | Sichuan Si Lu Kang Rui Pharma Co., Ltd. romanized |
| 2021/07/16New drug · Class 2.2 | BH002注射液 · No verified English nameCXHL2101297 | Zhuhai Bei Hai Bio Technology Co., Ltd. romanized |
| 2021/07/15Import · Class 2.4 | 硫酸阿托品滴眼液 · No verified English nameJXHL2101133 | ZHAOKE (HONG KONG) OPHTHALMOLOGY PHARMACEUTICAL LIMITED; ZHAOKE (GUANG ZHOU) OPHTHALMOLOGY PHARMACEUTICAL LIMITED |
| 2021/07/15Import · Class 2.4 | 硫酸阿托品滴眼液 · No verified English nameJXHL2101132 | ZHAOKE (HONG KONG) OPHTHALMOLOGY PHARMACEUTICAL LIMITED; ZHAOKE (GUANG ZHOU) OPHTHALMOLOGY PHARMACEUTICAL LIMITED |
| 2021/07/15Generic · Class 3 | Ambroxol Hydrochloride Oral SolutionCYHS2101438 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2021/07/15Generic · Class 3 | Digoxin InjectionCYHS2101427 | Shanghai Xu Dong Hai Pu Pharma Co., Ltd. romanized |
| 2021/07/15Generic · Class 3 | Levetiracetam extended-release tabletsCYHS2101407 | Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized; Changzhou Pharmaceutical Factory Co., Ltd. romanized |
| 2021/07/15New drug · Class 1 | 注射用TJ011133 · No verified English nameCXSL2101200 | Tian Jing Bio Technology (Shanghai) Co., Ltd. romanized |
| 2021/07/15New drug · Class 1 | SynOV1.1腺病毒注射液 · No verified English nameCXSL2101198 | Beijing He Sheng Ji Yin Technology Co., Ltd. romanized |
| 2021/07/15New drug · Class 3.3 | LY05008注射液 · No verified English nameCXSL2101197 | Shandong Bo An Bio Technology Co., Ltd. romanized |
| 2021/07/15New drug · Class 3.3 | LY05008注射液 · No verified English nameCXSL2101196 | Shandong Bo An Bio Technology Co., Ltd. romanized |
| 2021/07/15New drug · Class 1 | CM355 · No verified English nameCXSL2101185 | Beijing Tian Nuo Jian Cheng Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/07/15New drug · Class 1 | 注射用HS-20089 · No verified English nameCXSL2101180 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
27 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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