YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 279 drug applications between 2 August 2022 and 8 August 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 54, covering 44 drug names.
2022/08/02 – 2022/08/08
- New acceptances this week
- 279
- Drugs with new generic filings (by drug name, de-duplicated)
- 44
- 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
279filings, 54 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 145 |
| Generic | 54 |
| New drug | 46 |
| Import | 21 |
| Unspecified | 8 |
| Import re-registration | 4 |
| Drug-device combination product | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 201 |
| TCM | 44 |
| Therapeutic biologic | 29 |
| Prophylactic biologic | 3 |
| Biologic | 2 |
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
44 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ozagrel Sodium Injection | 4 | 2 | 3 |
| 2 | Sevelamer Carbonate Tablets | 2 | 2 | 4 |
| 3 | Acetylcysteine Granules | 2 | 1 | 4 |
| 4 | 头孢呋辛酯干混悬剂 · No verified English name | 2 | 1 | 5 |
| 5 | Ornidazole Injection | 2 | 1 | 0 |
| 6 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English name | 2 | 1 | 2 |
| 7 | 硫酸特布他林雾化吸入用溶液 · No verified English name | 2 | 1 | 1 |
| 8 | Gadobutrol Injection | 2 | 1 | 8 |
| 9 | Tadalafil Tablets | 1 | 1 | 23 |
| 10 | 低钙腹膜透析液(乳酸盐-G1.5%) · No verified English name | 1 | 1 | 3 |
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
144 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 40 | 35 | 0 |
| 2 | Dong Ling Pharma Technology (Liaoning) Co., Ltd. romanized | 15 | 15 | 0 |
| 3 | Novartis Pharma AG | 10 | 6 | 0 |
| 4 | Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized | 8 | 1 | 0 |
| 5 | Celgene Corporation | 6 | 1 | 0 |
| 6 | Boehringer Ingelheim International GmbH | 5 | 5 | 0 |
| 7 | Guangxi Xiu Zheng Pharmaceutical Co., Ltd. romanized | 5 | 3 | 0 |
| 8 | Hainan Tao Sheng Pharmaceuticals Technology Research Institute Co., Ltd. romanized | 5 | 3 | 0 |
| 9 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 5 | 3 | 5 |
| 10 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized | 4 | 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
87 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/08/08Generic · Class 3 | Carbazochrome Sodium Sulfonate InjectionCYHS2201256 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2022/08/08Generic · Class 3 | Ampicillin Sodium For InjectionCYHS2201253 | Shanxi Ming Yu Bio Technology Co., Ltd. romanized; Shandong Lukang Pharmaceutical Co.,Ltd. |
| 2022/08/08Generic · Class 3 | Aripiprazole Oral SolutionCYHS2201251 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized |
| 2022/08/08Generic · Class 3 | Ornidazole InjectionCYHS2201250 | Xian Xin Bai Xin Pharmaceuticals Technology Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized |
| 2022/08/08Generic · Class 3 | Ornidazole InjectionCYHS2201249 | Xian Xin Bai Xin Pharmaceuticals Technology Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized |
| 2022/08/08Generic · Class 3 | Citicoline Sodium InjectionCYHS2201248 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2022/08/08Generic · Class 3 | 低钙腹膜透析液(乳酸盐-G2.5%) · No verified English nameCYHS2201233 | Anhui Feng Yuan Pharma Co., Ltd. romanized |
| 2022/08/08Generic · Class 3 | 低钙腹膜透析液(乳酸盐-G1.5%) · No verified English nameCYHS2201232 | Anhui Feng Yuan Pharma Co., Ltd. romanized |
| 2022/08/08New drug · Class 1.1 | 通降颗粒 · No verified English nameCXZL2200037 | Jian Min Pharma Group Co., Ltd. romanized |
| 2022/08/08New drug · Class 2.3 | 舒肝解郁胶囊 · No verified English nameCXZL2200036 | Sichuan Ji Sheng Tang Pharma Co., Ltd. romanized |
| 2022/08/08New drug · Class 1 | 欧司珀利单抗注射液 · No verified English nameCXSL2200365 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2022/08/08New drug · Class 1 | 重组人源化抗BTLA单克隆抗体注射液 · No verified English nameCXSL2200364 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/08/08New drug · Class 1 | LBL-007注射液 · No verified English nameCXSL2200363 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2022/08/08New drug · Class 3.4 | 聚乙二醇化人粒细胞刺激因子注射液 · No verified English nameCXSL2200346 | Ke Xing Biopharmaceutical Co., Ltd. romanized |
| 2022/08/08New drug · Class 2.1 | 盐酸左沙丁胺醇异丙托溴铵吸入溶液 · No verified English nameCXHL2200575 | Jiangsu He Chen Pharma Co., Ltd. romanized |
| 2022/08/08New drug · Class 2.4 | Lidocaine CataplasmsCXHL2200574 | Beijing Tai De Pharmaceutical Co., Ltd. romanized |
| 2022/08/08New drug · Class 1 | BEBT-503胶囊 · No verified English nameCXHL2200573 | Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized |
| 2022/08/08New drug · Class 1 | BEBT-503胶囊 · No verified English nameCXHL2200572 | Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized |
| 2022/08/08New drug · Class 2.2 | 盐酸溴己新分散片 · No verified English nameCXHL2200560 | Jiangxi Yi You Pharma Co., Ltd. romanized |
| 2022/08/08New drug · Class 2.2 | 盐酸溴己新分散片 · No verified English nameCXHL2200559 | Jiangxi Yi You Pharma Co., Ltd. romanized |
| 2022/08/05Import · Class 1 | BMS-986256胶囊 · No verified English nameJXHL2200235 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2022/08/05Import · Class 1 | BMS-986256胶囊 · No verified English nameJXHL2200234 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2022/08/05Import · Class 1 | 注射用替曲朵辛 · No verified English nameJXHL2200226 | WEX Pharmaceuticals Inc.; PPC China Corporation Limited |
| 2022/08/05Generic · Class 3 | Ketorolac Tromethamine InjectionCYHS2201244 | Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2022/08/05Generic · Class 3 | Ebastine Oral SolutionCYHS2201240 | Jiangsu Lianhuan Pharmaceutical Co.,Ltd.; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2022/08/05New drug · Class 1 | 注射用SHR-A1811 · No verified English nameCXSL2200362 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2022/08/05New drug · Class 1 | KP104注射液 · No verified English nameCXSL2200361 | Ke Yue Pharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2022/08/05New drug · Class 2.2 | 替雷利珠单抗注射液 · No verified English nameCXSL2200360 | Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized |
| 2022/08/05New drug · Class 1 | IMG-007注射液 · No verified English nameCXSL2200359 | Ying Mai Biopharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2022/08/05New drug · Class 1 | SHR-1701注射液 · No verified English nameCXSL2200358 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
57 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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