YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 205 drug applications between 8 March 2024 and 14 March 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 41, covering 32 drug names.
2024/03/08 – 2024/03/14
- New acceptances this week
- 205
- Drugs with new generic filings (by drug name, de-duplicated)
- 32
- 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
205filings, 41 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 92 |
| New drug | 43 |
| Generic | 41 |
| Import | 15 |
| Import re-registration | 11 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 136 |
| Therapeutic biologic | 39 |
| TCM | 25 |
| 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
32 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Methotrexate Injection | 3 | 2 | 11 |
| 2 | Tadalafil Tablets | 2 | 1 | 23 |
| 3 | 复方氨基酸(16)双肽(1)注射液 · No verified English name | 2 | 1 | 0 |
| 4 | Cefditoren Pivoxil Granules | 2 | 1 | 18 |
| 5 | 小儿复方氨基酸注射液(19AA-I) · No verified English name | 2 | 1 | 2 |
| 6 | Lasmiditan Tablets | 2 | 1 | 0 |
| 7 | Irinotecan Hydrochloride Injection | 2 | 1 | 2 |
| 8 | Amlodipine Besylate Tablets | 2 | 1 | 8 |
| 9 | Betamethasone Sodium Phosphate Injection | 1 | 1 | 5 |
| 10 | 吉非替尼片 · No verified English name | 1 | 1 | 1 |
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
120 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Ascendis Pharma Endocrinology Division A/S | 9 | 1 | 0 |
| 2 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 6 | 4 | 2 |
| 3 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized | 6 | 2 | 0 |
| 4 | Hui Rui Pharma (Hubei) Co., Ltd. romanized | 5 | 4 | 0 |
| 5 | Kyowa Kirin Co. Ltd. | 5 | 1 | 0 |
| 6 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Novartis Pharma Schweiz AG | 4 | 3 | 0 |
| 8 | Dr. Falk Pharma GmbH | 4 | 1 | 0 |
| 9 | Shanghai Pharmaceuticals Group Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized | 4 | 1 | 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
70 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2024/03/14New drug · Class 1 | CU-10101软膏 · No verified English nameCXHL2400273 | Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized |
| 2024/03/14New drug · Class 1 | CU-10101软膏 · No verified English nameCXHL2400272 | Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized |
| 2024/03/13Import · Class 1 | 盐酸来罗西利片 · No verified English nameJXHS2400020 | Genor Biopharma(USA) Inc.; Quotient Sciences - Philadelphia LLC; Genor Biopharma Co. Ltd |
| 2024/03/13Generic · Class 3 | Multiple Electrolyte Additive For InjectionCYHS2400820 | CISEN PHARMACEUTICAL CO., LTD. |
| 2024/03/13Generic · Class 3 | Famotidine InjectionCYHS2400817 | Hunan Bai Qi He Drug Research and Development Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2024/03/13Generic · Class 3 | Lasmiditan TabletsCYHL2400059 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2024/03/13Generic · Class 3 | Lasmiditan TabletsCYHL2400058 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2024/03/13New drug · Class 1 | ER2001注射液 · No verified English nameCXSL2400181 | Ai Ma Bio Technology (Nanjing) Co., Ltd. romanized |
| 2024/03/13New drug · Class 1.1 | 鼻喷重组呼吸道合胞病毒疫苗(5型副流感病毒载体) · No verified English nameCXSL2400180 | Guangzhou Si An Xin Bio Technology Co., Ltd. romanized |
| 2024/03/13New drug · Class 1 | 金纳单抗注射液 · No verified English nameCXSL2400179 | Changchun Jin Sai Pharma Co., Ltd. romanized |
40 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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