YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 161 drug applications between 14 February 2024 and 20 February 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 42, covering 32 drug names.
2024/02/14 – 2024/02/20
- New acceptances this week
- 161
- Drugs with new generic filings (by drug name, de-duplicated)
- 32
- Accepted this week, now under review
- 6
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
161filings, 42 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 84 |
| Generic | 42 |
| New drug | 26 |
| Import | 7 |
| Unspecified | 1 |
| Import re-registration | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 106 |
| TCM | 34 |
| Therapeutic biologic | 20 |
| 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
32 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Metformin Hydrochloride And Empagliflozin Extended Release Tablets | 3 | 1 | 12 |
| 2 | Topiroxostat Tablets | 3 | 1 | 0 |
| 3 | Latamoxef Sodium for Injection | 3 | 1 | 1 |
| 4 | Piperacillin Sodium for Injection | 2 | 1 | 16 |
| 5 | Azilsartan Medoxomil Potassium Tablets | 2 | 1 | 35 |
| 6 | Esomeprazole Magnesium for Delayed-release Oral Suspension | 2 | 1 | 4 |
| 7 | Fluvoxamine Maleate Tablets | 2 | 1 | 0 |
| 8 | Sodium Valproate Oral Solution | 1 | 1 | 1 |
| 9 | Perampanel oral suspension | 1 | 1 | 2 |
| 10 | 复方氨基酸注射液(17AA-Ⅲ) · No verified English name | 1 | 1 | 2 |
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
98 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shijiazhuang Yu Ze Tang Pharmaceutical Co., Ltd. romanized | 10 | 10 | 0 |
| 2 | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. | 10 | 3 | 0 |
| 3 | Qi Lu An Ti Pharmaceutical Co., Ltd. romanized | 6 | 2 | 3 |
| 4 | Sichuan Yi Ke Cao Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Chengdu Hua Jian Wei Lai Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 6 | Haerbin Kang Ze Yuan Pharma Co., Ltd. romanized | 3 | 3 | 0 |
| 7 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized | 3 | 2 | 3 |
| 8 | Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 3 | 2 | 3 |
| 9 | Zhong Fu Pharma Co., Ltd. romanized | 3 | 1 | 0 |
| 10 | Le Pu Pharma Co., Ltd. romanized | 3 | 1 | 3 |
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
56 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/02/20Import · Class 2.4 | 布地奈德硫酸沙丁胺醇吸入气雾剂 · No verified English nameJXHL2400036 | AstraZeneca Pharmaceuticals LP; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/02/20Generic · Class 3 | Levocetirizine dihydrochloride Oral SolutionCYHS2400642 | Shanxi Fu Ren Heng Feng Pharma Co., Ltd. romanized |
| 2024/02/20Generic · Class 3 | Isoniazid InjectionCYHS2400641 | Hebei Long Hai Pharma Co., Ltd. romanized; Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized |
| 2024/02/20Generic · Class 3 | Latamoxef Sodium for InjectionCYHS2400637 | Qi Lu An Ti Pharmaceutical Co., Ltd. romanized |
| 2024/02/20Generic · Class 3 | Latamoxef Sodium for InjectionCYHS2400636 | Qi Lu An Ti Pharmaceutical Co., Ltd. romanized |
| 2024/02/20Generic · Class 3 | Latamoxef Sodium for InjectionCYHS2400635 | Qi Lu An Ti Pharmaceutical Co., Ltd. romanized |
| 2024/02/20Generic · Class 3 | Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2400633 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized |
| 2024/02/20Generic · Class 3 | Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2400632 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized |
| 2024/02/20Generic · Class 3 | Esmolol Hydrochloride InjectionCYHS2400627 | Shanghai Xuan Xin Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2024/02/20Generic · Class 3 | Clindamycin Palmitate Hydrochloride GranulesCYHS2400625 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized |
| 2024/02/20Generic · Class 3 | Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2400624 | Le Pu Pharma Co., Ltd. romanized |
| 2024/02/20Generic · Class 3 | Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2400623 | Le Pu Pharma Co., Ltd. romanized |
| 2024/02/20Generic · Class 3 | Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2400622 | Le Pu Pharma Co., Ltd. romanized |
| 2024/02/20Generic · Class 3 | Topiroxostat TabletsCYHL2400043 | Hebei Kai Wei Heng Cheng Pharmaceutical Co., Ltd. romanized |
| 2024/02/20Generic · Class 3 | Topiroxostat TabletsCYHL2400042 | Hebei Kai Wei Heng Cheng Pharmaceutical Co., Ltd. romanized |
| 2024/02/20Generic · Class 3 | Topiroxostat TabletsCYHL2400041 | Hebei Kai Wei Heng Cheng Pharmaceutical Co., Ltd. romanized |
| 2024/02/20Generic · Class 3 | Brivaracetam Solution for InjectionCYHL2400040 | Jiangxi Yin Tao Pharma Co., Ltd. romanized |
| 2024/02/20New drug · Class 1 | 注射用ZB001 · No verified English nameCXSL2400133 | Shanghai Ze Na Shi Bio Technology Co., Ltd. romanized |
| 2024/02/20New drug · Class 1 | TVAX-008注射液 · No verified English nameCXSL2400132 | Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Nanjing) Co., Ltd. romanized; Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Hangzhou) Co., Ltd. romanized |
| 2024/02/20New drug · Class 2.5 | 带状疱疹减毒活疫苗 · No verified English nameCXSL2400131 | Chengdu Bai Ao Te Ke Bio Technology Co., Ltd. romanized |
| 2024/02/20New drug · Class 1 | 注射用KKD001 · No verified English nameCXSL2400130 | Shang Rao Shi Kang Ke De Bio Technology Co., Ltd. romanized |
| 2024/02/20New drug · Class 1 | SHR-2173注射液 · No verified English nameCXSL2400129 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/02/20New drug · Class 1 | 注射用SHR-A1921 · No verified English nameCXSL2400128 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2024/02/20New drug · Class 1 | 注射用SHR-A2009 · No verified English nameCXSL2400127 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2024/02/20New drug · Class 1 | 注射用SHR-9839 · No verified English nameCXSL2400126 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/02/20New drug · Class 1 | EMB-06注射液 · No verified English nameCXSL2400125 | Shanghai An Mai Bio Technology Co., Ltd. romanized |
| 2024/02/20New drug · Class 1 | ADRX-0706 · No verified English nameCXSL2400124 | Shanghai De Feng Pharma Co., Ltd. romanized |
| 2024/02/20New drug · Class 2.2 | 盐酸氨溴索口服冻干片 · No verified English nameCXHS2400014 | China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd.; Shaanxi Liang Zi Gao Ke Pharma Co., Ltd. romanized |
| 2024/02/20New drug · Class 2.2 | 盐酸氨溴索口服冻干片 · No verified English nameCXHS2400013 | China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd.; Shaanxi Liang Zi Gao Ke Pharma Co., Ltd. romanized |
| 2024/02/20New drug · Class 1 | INR101注射液 · No verified English nameCXHL2400200 | Yun He Pharmaceuticals (Tianjin) Co., Ltd. romanized |
26 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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