YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 360 drug applications between 21 December 2023 and 27 December 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 106, covering 78 drug names.
2023/12/21 – 2023/12/27
- New acceptances this week
- 360
- Drugs with new generic filings (by drug name, de-duplicated)
- 78
- Accepted this week, now under review
- 1
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
360filings, 106 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 155 |
| Generic | 106 |
| New drug | 60 |
| Import | 21 |
| Import re-registration | 11 |
| Unspecified | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 253 |
| TCM | 61 |
| Therapeutic biologic | 42 |
| Prophylactic biologic | 3 |
| 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
78 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 4 | 2 | 60 |
| 2 | Levofloxacin and Sodium Chloride Injection | 4 | 2 | 14 |
| 3 | Potassium Chloride Injection | 3 | 2 | 10 |
| 4 | Ketorolac Tromethamine Injection | 3 | 2 | 4 |
| 5 | Telmisartan And Amlodipine Tablets | 2 | 2 | 10 |
| 6 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 2 | 2 | 23 |
| 7 | Ceftazidime And Avibactam Sodium For Injection | 2 | 2 | 12 |
| 8 | Nefopam Hydrochloride Injection | 2 | 2 | 3 |
| 9 | 腺苷钴胺胶囊 · No verified English name | 2 | 2 | 8 |
| 10 | Lactulose Oral Solution | 2 | 1 | 34 |
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
213 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bo Rui Xin Chuang Biopharmaceuticals Technology (Wuxi) Co., Ltd. romanized | 14 | 1 | 0 |
| 2 | Shenyang Hong Yao Group Co., Ltd. romanized | 7 | 6 | 0 |
| 3 | AstraZeneca AB | 7 | 4 | 0 |
| 4 | Guizhou Bai Ling Qi Ye Group Pharmaceutical Co., Ltd. romanized | 6 | 3 | 0 |
| 5 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 6 | 2 | 0 |
| 6 | Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Beijing Bu Lin Bio Technology Co., Ltd. romanized | 5 | 3 | 5 |
| 8 | Guangzhou Bai Yun Shan Tian Xin Pharmaceutical Co., Ltd. romanized | 5 | 3 | 0 |
| 9 | Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized | 5 | 1 | 0 |
| 10 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | 4 | 4 | 4 |
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
121 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/12/27Generic · Class 3 | Nefopam Hydrochloride InjectionCYHS2303644 | Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized |
| 2023/12/27Generic · Class 3 | Nicorandil for InjectionCYHS2303641 | Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/12/27Generic · Class 3 | Acetylcysteine Oral SolutionCYHS2303640 | Nanjing Yi Teng Drug Research Institute Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2023/12/27Generic · Class 3 | Potassium Chloride InjectionCYHS2303635 | Fujian Xin Di Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2023/12/27Generic · Class 3 | 左羟丙哌嗪口服溶液 · No verified English nameCYHS2303634 | Anhui Mao Kang Pharma Co., Ltd. romanized; Anhui Xin Shi Ji Pharma Co., Ltd. romanized |
| 2023/12/27Generic · Class 3 | 左羟丙哌嗪口服溶液 · No verified English nameCYHS2303633 | Anhui Mao Kang Pharma Co., Ltd. romanized; Anhui Xin Shi Ji Pharma Co., Ltd. romanized |
| 2023/12/27Generic · Class 3 | Gabexate Mesilate For InjectionCYHS2303631 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2023/12/27Generic · Class 3 | Procaterol Hydrochloride Oral SolutionCYHS2303630 | Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized |
| 2023/12/27Generic · Class 3 | Dexmethylphenidate Hydrochloride Exended-release CapsulesCYHS2303628 | Henan Zhong Shuai Pharma Co., Ltd. romanized |
| 2023/12/27Generic · Class 3 | Propafenone Hydrochloride InjectionCYHS2303627 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2023/12/27Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2303626 | Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized |
| 2023/12/27Generic · Class 3 | Epinephrine InjectionCYHS2303624 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2023/12/27Generic · Class 3 | 膀胱灌注用盐酸氨酮戊酸己酯及专用溶剂 · No verified English nameCYHL2300161 | Guangdong Jing Guan Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/12/27Generic · Class 3 | Pregabalin Extended release TabletsCYHL2300160 | Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized |
| 2023/12/27New drug · Class 1.1 | 椒七麝凝胶贴膏 · No verified English nameCXZS2300028 | Hunan Jiudian Pharmaceutical Co., Ltd |
| 2023/12/27New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2300896 | Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized |
| 2023/12/27New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2300895 | Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized |
| 2023/12/27New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2300894 | Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized |
| 2023/12/27New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2300893 | Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized |
| 2023/12/27New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2300892 | Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized |
| 2023/12/27New drug · Class 1 | LM-101注射液 · No verified English nameCXSL2300891 | Li Xin Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/12/27New drug · Class 1 | 昂拉地韦片 · No verified English nameCXHS2300118 | Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized; Guangdong Hua Nan Pharma Group Co., Ltd. romanized |
| 2023/12/27New drug · Class 1 | NS-041分散片 · No verified English nameCXHL2301454 | Niu Ou Shen Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2023/12/27New drug · Class 1 | NS-041分散片 · No verified English nameCXHL2301453 | Niu Ou Shen Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2023/12/27New drug · Class 2.2 | 小儿泼尼松肠溶干混悬剂(微球型) · No verified English nameCXHL2301452 | Wen Tao Innovation Drug Research (Beijing) Co., Ltd. romanized |
| 2023/12/27New drug · Class 2.2 | 泼尼松肠溶胶囊(微球型) · No verified English nameCXHL2301451 | Wen Tao Innovation Drug Research (Beijing) Co., Ltd. romanized |
| 2023/12/27New drug · Class 2.2; 2.4 | 硫酸阿托品滴眼液 · No verified English nameCXHL2301450 | Le Pu Pharma Co., Ltd. romanized |
| 2023/12/27New drug · Class 2.2; 2.4 | 硫酸阿托品滴眼液 · No verified English nameCXHL2301449 | Le Pu Pharma Co., Ltd. romanized |
| 2023/12/26Import · Class 2.2 | Benralizumab注射液 · No verified English nameJXSL2300235 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/12/26Import · Class 1 | BI1569912 片 · No verified English nameJXHL2300328 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
91 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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