YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 114 drug applications between 8 August 2023 and 14 August 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 26, covering 18 drug names.
2023/08/08 – 2023/08/14
- New acceptances this week
- 114
- Drugs with new generic filings (by drug name, de-duplicated)
- 18
- 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
114filings, 26 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 50 |
| Generic | 26 |
| Import re-registration | 18 |
| New drug | 15 |
| Unspecified | 4 |
| Import | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 69 |
| TCM | 26 |
| Therapeutic biologic | 16 |
| Prophylactic biologic | 2 |
| 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
18 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Tacrolimus Sustained-release Capsules | 2 | 1 | 6 |
| 2 | Piracetam Injection | 2 | 1 | 9 |
| 3 | 昂丹司琼口溶膜 · No verified English name | 2 | 1 | 2 |
| 4 | Aminophylline Injection | 2 | 1 | 3 |
| 5 | Pegaspargase For Injection | 2 | 1 | 0 |
| 6 | Nicorandil for Injection | 2 | 1 | 1 |
| 7 | Esomeprazole Sodium for Injection | 2 | 1 | 1 |
| 8 | Mivacurium Chloride Injection | 2 | 1 | 3 |
| 9 | 二甲双胍恩格列净片(Ⅴ) · No verified English name | 1 | 1 | 0 |
| 10 | Formoterol Fumarate Inhalation Solution | 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
62 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | GE Healthcare AS | 14 | 1 | 0 |
| 2 | Shenyang Qing Gong Pharma Group Co., Ltd. romanized | 9 | 9 | 0 |
| 3 | Changsha Ai Bei Gao Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Wuxi Fu Qi Pharmaceutical Co., Ltd. romanized | 4 | 1 | 0 |
| 5 | Jiangsu Xing Sheng Xin Hui Pharmaceuticals Co., Ltd. romanized | 3 | 1 | 0 |
| 6 | Zhejiang Ya Tai Pharma Co., Ltd. romanized | 3 | 1 | 0 |
| 7 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized | 2 | 2 | 0 |
| 8 | Heng Tuo Group Guangxi Sheng Kang Pharmaceutical Co., Ltd. romanized | 2 | 2 | 0 |
| 9 | Heilongjiang Wu Su Li Jiang Pharmaceutical Co., Ltd. romanized | 2 | 2 | 0 |
| 10 | Amgen Inc. | 2 | 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
28 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/08/14Generic · Class 3 | Aminophylline InjectionCYHS2302103 | Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2023/08/14Generic · Class 3 | Aminophylline InjectionCYHS2302102 | Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2023/08/14New drug · Class 1 | WXFL10203614片 · No verified English nameCXHL2300862 | Wuxi Fu Qi Pharmaceutical Co., Ltd. romanized |
| 2023/08/14New drug · Class 1 | WXFL10203614片 · No verified English nameCXHL2300861 | Wuxi Fu Qi Pharmaceutical Co., Ltd. romanized |
| 2023/08/12Generic · Class 3 | Piracetam InjectionCYHS2302098 | Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Guo Yao Group Guo Rui Pharma Co., Ltd. romanized |
| 2023/08/12Generic · Class 3 | Piracetam InjectionCYHS2302097 | Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Guo Yao Group Guo Rui Pharma Co., Ltd. romanized |
| 2023/08/12Generic · Class 3 | Regadenoson InjectionCYHS2302096 | Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized |
| 2023/08/12Generic · Class 3 | Nicorandil for InjectionCYHS2302095 | HAINAN HUALON PHARMACEUTICAL CO.,LTD |
| 2023/08/12Generic · Class 3 | Nicorandil for InjectionCYHS2302094 | HAINAN HUALON PHARMACEUTICAL CO.,LTD |
| 2023/08/12Generic · Class 3 | 昂丹司琼口溶膜 · No verified English nameCYHS2302092 | Jiangsu He Chen Pharma Co., Ltd. romanized |
| 2023/08/12Generic · Class 3 | 昂丹司琼口溶膜 · No verified English nameCYHS2302091 | Jiangsu He Chen Pharma Co., Ltd. romanized |
| 2023/08/12Generic · Class 3 | Pegaspargase For InjectionCYHS2302085 | Beijing SL Pharmaceutical Co., Ltd. |
| 2023/08/12Generic · Class 3 | Pegaspargase For InjectionCYHS2302083 | Beijing SL Pharmaceutical Co., Ltd. |
| 2023/08/12New drug · Class 1 | 艾帕洛利单抗托沃瑞利单抗注射液 · No verified English nameCXSS2300066 | Qilu Pharmaceutical Co., Ltd. |
| 2023/08/12New drug · Class 3.3 | 乌司奴单抗注射液 · No verified English nameCXSS2300065 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized; Jiangsu Sai Fu Shi Bio Technology Co., Ltd. romanized |
| 2023/08/12New drug · Class 1 | QX005N注射液 · No verified English nameCXSL2300540 | Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized |
| 2023/08/12New drug · Class 1 | RRG001眼内注射液 · No verified English nameCXSL2300539 | Shanghai Ding Xin Ji Yin Technology Co., Ltd. romanized |
| 2023/08/12New drug · Class 1 | 注射用NBL-028 · No verified English nameCXSL2300538 | Shanghai Xin Shi Biopharmaceuticals Co., Ltd. romanized |
| 2023/08/12New drug · Class 1 | WXFL10203614片 · No verified English nameCXHL2300860 | Wuxi Fu Qi Pharmaceutical Co., Ltd. romanized |
| 2023/08/12New drug · Class 1 | WXFL10203614片 · No verified English nameCXHL2300859 | Wuxi Fu Qi Pharmaceutical Co., Ltd. romanized |
| 2023/08/12New drug · Class 1 | XS-03片 · No verified English nameCXHL2300858 | Jiangsu Xing Sheng Xin Hui Pharmaceuticals Co., Ltd. romanized |
| 2023/08/12New drug · Class 1 | XS-03片 · No verified English nameCXHL2300857 | Jiangsu Xing Sheng Xin Hui Pharmaceuticals Co., Ltd. romanized |
| 2023/08/12New drug · Class 1 | XS-03片 · No verified English nameCXHL2300856 | Jiangsu Xing Sheng Xin Hui Pharmaceuticals Co., Ltd. romanized |
| 2023/08/12New drug · Class 2.4 | 枸橼酸坦度螺酮胶囊 · No verified English nameCXHL2300855 | Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized |
| 2023/08/12New drug · Class 2.4 | 枸橼酸坦度螺酮胶囊 · No verified English nameCXHL2300854 | Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized |
| 2023/08/11Generic · Class 3 | Peramivir InjectionCYHS2302082 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized |
| 2023/08/10Generic · Class 3 | Salbutamol Sulfate injectionCYHS2302079 | Sichuan Guo Rui Pharma Co., Ltd. romanized |
| 2023/08/10New drug · Class 1 | M108单抗注射液 · No verified English nameCXSL2300537 | Ming Ji Biopharmaceutical (Beijing) Co., Ltd. romanized |
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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