YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 239 drug applications between 11 March 2024 and 17 March 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 57, covering 42 drug names.
2024/03/11 – 2024/03/17
- New acceptances this week
- 239
- Drugs with new generic filings (by drug name, de-duplicated)
- 42
- 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
239filings, 57 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 105 |
| Generic | 57 |
| New drug | 43 |
| Import re-registration | 14 |
| Import | 12 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 162 |
| TCM | 35 |
| Therapeutic biologic | 31 |
| Biologic | 7 |
| 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
42 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Amlodipine Besylate Tablets | 4 | 2 | 8 |
| 2 | Methotrexate Injection | 3 | 2 | 11 |
| 3 | Tadalafil Tablets | 3 | 1 | 23 |
| 4 | Ethyl Iosapentate Capsules | 2 | 1 | 27 |
| 5 | Carbidopa and Levodopa Sustained-release Tablets | 2 | 1 | 2 |
| 6 | Perampanel Tablets | 2 | 1 | 2 |
| 7 | Cefditoren Pivoxil Granules | 2 | 1 | 18 |
| 8 | Montelukast Sodium Chewable Tablets | 2 | 1 | 4 |
| 9 | 小儿复方氨基酸注射液(19AA-I) · No verified English name | 2 | 1 | 2 |
| 10 | Lasmiditan Tablets | 2 | 1 | 0 |
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
138 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Henan Shuang He Hua Li Pharma Co., Ltd. romanized | 14 | 3 | 0 |
| 2 | Guo Da (Jilin) Pharmaceutical Group Co., Ltd. romanized | 9 | 9 | 0 |
| 3 | Hui Rui Pharma (Hubei) Co., Ltd. romanized | 7 | 6 | 0 |
| 4 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 6 | 4 | 2 |
| 5 | Shanghai Ai Bo Pharmaceuticals Technology Co., Ltd. romanized | 4 | 2 | 0 |
| 6 | Dr. Falk Pharma GmbH | 4 | 1 | 0 |
| 7 | Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized | 4 | 1 | 0 |
| 8 | Hainan Ling Kang Pharmaceutical Co., Ltd. romanized | 4 | 1 | 0 |
| 9 | Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Boehringer Ingelheim International GmbH | 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
67 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/03/16Import · Class 1 | 注射用Datopotamab Deruxtecan · No verified English nameJXSS2400026 | Daiichi Sankyo Europe GmbH; Baxter Oncology GmbH; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2024/03/16Import · Class 1 | ABBV-400注射用粉末 · No verified English nameJXSL2400060 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2024/03/16New drug · Class 2.2 | 聚乙二醇干扰素α-2b注射液 · No verified English nameCXSS2400026 | Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized |
| 2024/03/16New drug · Class 2.2 | 聚乙二醇干扰素α-2b注射液 · No verified English nameCXSS2400025 | Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized |
| 2024/03/16New drug · Class 2.2 | 聚乙二醇干扰素α-2b注射液 · No verified English nameCXSS2400024 | Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized |
| 2024/03/16New drug · Class 2.2 | 聚乙二醇干扰素α-2b注射液 · No verified English nameCXSS2400023 | Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized |
| 2024/03/16New drug · Class 1 | 注射用苏维西塔单抗 · No verified English nameCXSS2400022 | Jiangsu Xian Sheng Biopharmaceutical Co., Ltd. romanized |
| 2024/03/16New drug · Class 1 | BAT6005注射液 · No verified English nameCXSL2400189 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2024/03/16New drug · Class 1 | BAT1308注射液 · No verified English nameCXSL2400188 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2024/03/16New drug · Class 1.2 | 呼吸道合胞病毒IN006二价mRNA疫苗 · No verified English nameCXSL2400187 | Shenzhen Shen Xin Bio Technology Co., Ltd. romanized |
| 2024/03/16New drug · Class 1 | ABP1618片 · No verified English nameCXHL2400285 | Shanghai Ai Bo Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/03/16New drug · Class 1 | ABP1618片 · No verified English nameCXHL2400284 | Shanghai Ai Bo Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/03/15Import · Class 2.2; 2.4 | TAR-210 · No verified English nameJXHL2400065 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/03/15Import · Class 1 | Balcinrenone达格列净胶囊 · No verified English nameJXHL2400064 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/03/15Import · Class 1 | Balcinrenone达格列净胶囊 · No verified English nameJXHL2400063 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/03/15Generic · Class 3 | Atropine Sulfate InjectionCYHS2400853 | Jiangsu Kai Yuan Pharma Co., Ltd. romanized; Kang Pu Pharma Co., Ltd. romanized |
| 2024/03/15Generic · Class 3 | 普仑司特干糖浆 · No verified English nameCYHS2400849 | Ji Chuan Pharma Group Co., Ltd. romanized |
| 2024/03/15Generic · Class 3 | Cimetidine InjectionCYHS2400845 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized |
| 2024/03/15Generic · Class 3 | 复方聚乙二醇电解质散(儿童型) · No verified English nameCYHS2400838 | Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2024/03/15New drug · Class 1 | SHR-4849注射液 · No verified English nameCXSL2400186 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/03/15New drug · Class 1 | FC084CSA片 · No verified English nameCXHL2400283 | Zhong Shan Yi Nuo Wei Shen Xin Yao Research and Development Co., Ltd. romanized |
| 2024/03/15New drug · Class 1 | FC084CSA片 · No verified English nameCXHL2400282 | Zhong Shan Yi Nuo Wei Shen Xin Yao Research and Development Co., Ltd. romanized |
| 2024/03/14Import · Class 1 | BI 1839100 片 · No verified English nameJXHL2400062 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2024/03/14Generic · Class 3 | 溴吡斯的明缓释片 · No verified English nameCYHS2400832 | Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized |
| 2024/03/14Generic · Class 3 | 小儿复方氨基酸注射液(19AA-I) · No verified English nameCYHS2400830 | Hubei Min Kang Pharma Group Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2024/03/14Generic · Class 3 | 小儿复方氨基酸注射液(19AA-I) · No verified English nameCYHS2400829 | Hubei Min Kang Pharma Group Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2024/03/14Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2400827 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2024/03/14Generic · Class 3 | 盐酸麻黄碱注射液 · No verified English nameCYHS2400825 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2024/03/14Generic · Class 3 | Betamethasone Sodium Phosphate InjectionCYHS2400824 | Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized |
| 2024/03/14New drug · Class 1.1 | 温肺定喘颗粒 · No verified English nameCXZL2400015 | Shandong Kang Zhong Hong Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
37 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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