YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 228 drug applications between 9 March 2024 and 15 March 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 50, covering 37 drug names.
2024/03/09 – 2024/03/15
- New acceptances this week
- 228
- Drugs with new generic filings (by drug name, de-duplicated)
- 37
- 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
228filings, 50 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 110 |
| Generic | 50 |
| New drug | 37 |
| Import re-registration | 14 |
| Import | 9 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 158 |
| Therapeutic biologic | 35 |
| TCM | 25 |
| Biologic | 7 |
| Prophylactic biologic | 3 |
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
37 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 | Cefditoren Pivoxil Granules | 2 | 1 | 18 |
| 7 | 小儿复方氨基酸注射液(19AA-I) · No verified English name | 2 | 1 | 2 |
| 8 | Lasmiditan Tablets | 2 | 1 | 0 |
| 9 | Irinotecan Hydrochloride Injection | 2 | 1 | 2 |
| 10 | Lactulose Oral Solution | 1 | 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
129 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 | Hui Rui Pharma (Hubei) Co., Ltd. romanized | 7 | 6 | 0 |
| 3 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 6 | 4 | 2 |
| 4 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized | 6 | 2 | 0 |
| 5 | Kyowa Kirin Co. Ltd. | 5 | 1 | 0 |
| 6 | Dr. Falk Pharma GmbH | 4 | 1 | 0 |
| 7 | Hainan Ling Kang Pharmaceutical Co., Ltd. romanized | 4 | 1 | 0 |
| 8 | Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized | 4 | 1 | 0 |
| 9 | Boehringer Ingelheim International GmbH | 3 | 3 | 0 |
| 10 | Novartis Pharma Schweiz AG | 3 | 2 | 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
59 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2024/03/14New drug · Class 1 | 注射用YL205 · No verified English nameCXSL2400185 | Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized |
| 2024/03/14New drug · Class 1 | SSGJ-707注射液 · No verified English nameCXSL2400184 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized; San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2024/03/14New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSL2400183 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2024/03/14New drug · Class 1 | SI-B001双特异性抗体注射液 · No verified English nameCXSL2400182 | Sichuan Bai Li Pharma Co., Ltd. romanized; Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized |
| 2024/03/14New drug · Class 1 | F230片 · No verified English nameCXHL2400281 | Beijing Kang Di Ni Pharma Co., Ltd. romanized |
| 2024/03/14New drug · Class 1 | F230片 · No verified English nameCXHL2400280 | Beijing Kang Di Ni Pharma Co., Ltd. romanized |
| 2024/03/14New drug · Class 1 | F230片 · No verified English nameCXHL2400279 | Beijing Kang Di Ni Pharma Co., Ltd. romanized |
| 2024/03/14New drug · Class 1 | 替古索司他片 · No verified English nameCXHL2400278 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2024/03/14New drug · Class 1 | 替古索司他片 · No verified English nameCXHL2400277 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2024/03/14New drug · Class 1 | 替古索司他片 · No verified English nameCXHL2400276 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2024/03/14New drug · Class 1 | CU-10101软膏 · No verified English nameCXHL2400275 | Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized |
| 2024/03/14New drug · Class 1 | CU-10101软膏 · No verified English nameCXHL2400274 | Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized |
29 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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