YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 352 drug applications between 19 October 2023 and 25 October 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 103, covering 78 drug names.
2023/10/19 – 2023/10/25
- New acceptances this week
- 352
- Drugs with new generic filings (by drug name, de-duplicated)
- 78
- Accepted this week, now under review
- 2
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
352filings, 103 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 172 |
| Generic | 103 |
| New drug | 55 |
| Import | 16 |
| Unspecified | 3 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 264 |
| TCM | 55 |
| Therapeutic biologic | 29 |
| Prophylactic biologic | 4 |
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 | Acetylcysteine Oral Solution | 3 | 1 | 11 |
| 2 | Nicardipine Hydrochloride Injection | 3 | 1 | 13 |
| 3 | Sodium Valproate Sustained-release Tablets(I) | 2 | 2 | 4 |
| 4 | 地氯雷他定口服溶液 · No verified English name | 2 | 2 | 26 |
| 5 | Ambroxol Hydrochloride Solution For Inhalation | 2 | 1 | 10 |
| 6 | Candesartan Cilexetil and Hydrochlorothiazide Tablets | 2 | 1 | 0 |
| 7 | 复方电解质醋酸钠葡萄糖注射液 · No verified English name | 2 | 1 | 22 |
| 8 | Olanzapine Tablets | 2 | 1 | 4 |
| 9 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 10 | Metformin Hydrochloride And Empagliflozin Extended Release 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
229 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized | 11 | 10 | 0 |
| 2 | Hainan Pu Li Pharmaceutical Co., Ltd. romanized | 9 | 1 | 0 |
| 3 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 5 | 4 | 4 |
| 4 | Shang Qiu Shi Xin Ma Bio Technology Co., Ltd. romanized | 4 | 4 | 0 |
| 5 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 6 | JANSSEN-CILAG NV | 4 | 1 | 0 |
| 7 | TRUEMED LTD. | 4 | 1 | 0 |
| 8 | Shanghai Shang Yao Xin Ya Pharma Co., Ltd. romanized | 4 | 1 | 0 |
| 9 | Changchun Jin Sai Pharma Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Shanxi Guang Yu Yuan Guo Yao Co., Ltd. romanized | 3 | 3 | 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
114 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/10/25Import · Class 1 | BMS-986435片 · No verified English nameJXHL2300267 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2023/10/25Generic · Class 3 | Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2302896 | Rui Yang Pharmaceutical Co., Ltd. romanized |
| 2023/10/25Generic · Class 3 | Potassium Chloride GranulesCYHS2302895 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2023/10/25Generic · Class 3 | Calcium Acetate TabletsCYHS2302887 | Qingdao Bai Yang Pharmaceutical Co., Ltd. romanized |
| 2023/10/25Generic · Class 3 | Tolvaptan Orally Disintegrating TabletsCYHS2302886 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2023/10/25Generic · Class 3 | Tolvaptan Orally Disintegrating TabletsCYHS2302885 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2023/10/25Generic · Class 3 | Minoxidil LinimentCYHS2302884 | Tai Kang Hai En Pharma Co., Ltd. romanized |
| 2023/10/25Generic · Class 3 | Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2302883 | Chengdu Di Ao Pharmaceutical Group Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized |
| 2023/10/25Generic · Class 3 | Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2302882 | Chengdu Di Ao Pharmaceutical Group Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized |
| 2023/10/25New drug · Class 1 | MBS314注射液 · No verified English nameCXSL2300727 | Kang Yuan Bo Chuang Bio Technology (Beijing) Co., Ltd. romanized; Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized |
| 2023/10/25New drug · Class 1 | BRL03注射液 · No verified English nameCXSL2300726 | Guangzhou Bai Ji Biopharmaceutical Co., Ltd. romanized |
| 2023/10/25New drug · Class 1 | 注射用SC-101 · No verified English nameCXHL2301161 | Tianjin Xing Lian Tai Bio Technology Co., Ltd. romanized |
| 2023/10/25New drug · Class 2.2 | SXF-100口溶膜 · No verified English nameCXHL2301160 | Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized |
| 2023/10/25New drug · Class 1 | ACC017片 · No verified English nameCXHL2301159 | Chengdu Ai Di Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Ai Di Pharma Co., Ltd. romanized; Nanjing Ai Di Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/10/25New drug · Class 1 | ACC017片 · No verified English nameCXHL2301158 | Chengdu Ai Di Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Ai Di Pharma Co., Ltd. romanized; Nanjing Ai Di Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/10/24Import · Class 2.3; 2.4 | 卡巴胆碱溴莫尼定滴眼液 · No verified English nameJXHL2300266 | Visus Therapeutics Inc.; Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Co. Ltd. |
| 2023/10/24Generic · Class 3 | Atropine Sulfate InjectionCYHS2302875 | Hunan Hai Shi Biopharmaceuticals Co., Ltd. romanized; Kang Pu Pharma Co., Ltd. romanized |
| 2023/10/24Generic · Class 3 | Torsemide InjectionCYHS2302873 | Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2023/10/24Generic · Class 3 | Torsemide InjectionCYHS2302872 | Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2023/10/24Generic · Class 3 | Celecoxib TabletsCYHS2302870 | Kunming Yuan Rui Pharmaceutical Co., Ltd. romanized |
| 2023/10/24Generic · Class 3 | Dihydroxyaluminum Aminoacetate, Heavy Magnesium Carbonate and Aspirin Tablets(Ⅱ)CYHS2302866 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2023/10/24Generic · Class 3 | Acetylcysteine Oral SolutionCYHS2302858 | Sichuan Hai Meng Zhi Sen Biopharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2023/10/24Generic · Class 3 | Acetylcysteine Oral SolutionCYHS2302857 | Sichuan Hai Meng Zhi Sen Biopharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2023/10/24Generic · Class 3 | Acetylcysteine Oral SolutionCYHS2302856 | Sichuan Hai Meng Zhi Sen Biopharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2023/10/24Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2302851 | Sichuan Miao Ji Biopharmaceuticals Technology Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized |
| 2023/10/24Generic · Class 3 | Haloperidol Lactate InjectionCYHS2302850 | Anhui Chang Jiang Pharma Co., Ltd. romanized |
| 2023/10/24Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2302849 | Hunan Jia Heng Pharmaceutical Co., Ltd. romanized |
| 2023/10/24New drug · Class 1 | RJMty19注射液 · No verified English nameCXSL2300725 | Guangdong Rui Shun Bio Technology Co., Ltd. romanized |
| 2023/10/24New drug · Class 1 | 重组人血清白蛋白注射液 · No verified English nameCXSL2300724 | Shandong Jian Tong Bio Technology Co., Ltd. romanized |
| 2023/10/24New drug · Class 1 | STSA-1001注射液 · No verified English nameCXSL2300723 | Shu Tai Shen (Beijing) Biopharmaceutical Co., Ltd. romanized |
84 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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