YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 308 drug applications between 26 November 2023 and 2 December 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 68, covering 56 drug names.
2023/11/26 – 2023/12/02
- New acceptances this week
- 308
- Drugs with new generic filings (by drug name, de-duplicated)
- 56
- 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
308filings, 68 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 161 |
| Generic | 68 |
| New drug | 53 |
| Import | 21 |
| Import re-registration | 3 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 199 |
| Therapeutic biologic | 57 |
| TCM | 45 |
| Prophylactic biologic | 5 |
| 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
56 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Tadalafil Tablets | 3 | 1 | 23 |
| 2 | 地氯雷他定口服溶液 · No verified English name | 3 | 1 | 26 |
| 3 | Acetylcysteine Injection | 2 | 2 | 53 |
| 4 | Moxifloxacin Hydrochloride Eye Drops | 2 | 2 | 4 |
| 5 | Risperidone Tablets | 2 | 1 | 0 |
| 6 | 布洛芬混悬滴剂 · No verified English name | 2 | 1 | 0 |
| 7 | Sildenafil Citrate Tablets | 2 | 1 | 12 |
| 8 | Amisulpride Injection | 2 | 1 | 1 |
| 9 | Thioctic Acid Tablets | 2 | 1 | 4 |
| 10 | Roxadustat Capsules | 2 | 1 | 17 |
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
191 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shanxi Zhen Dong Pharmaceutical Co., Ltd. romanized | 10 | 10 | 0 |
| 2 | Merck Sharp & Dohme LLC | 7 | 2 | 0 |
| 3 | CSL Behring GmbH | 7 | 1 | 0 |
| 4 | Hainan Ying Da Run Ze Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Shanxi Shuang Yan Pharma Co., Ltd. romanized | 5 | 4 | 0 |
| 6 | Chongqing Xi Er An Pharma Co., Ltd. romanized | 5 | 4 | 0 |
| 7 | AstraZeneca AB | 5 | 2 | 0 |
| 8 | Shandong Er Ye Pharmaceutical Co., Ltd. romanized | 5 | 1 | 0 |
| 9 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized | 4 | 2 | 2 |
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
103 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/12/02Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSS2300085 | Merck Sharp & Dohme LLC; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd |
| 2023/12/02Import · Class 1 | AZD5305 · No verified English nameJXHL2300300 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/12/02Import · Class 1 | AZD5305 · No verified English nameJXHL2300299 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/12/02Import · Class 1 | AZD5305 · No verified English nameJXHL2300298 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/12/02Import · Class 1 | AZD5305 · No verified English nameJXHL2300297 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/12/02Generic · Class 3 | 富马酸酮替芬滴眼液 · No verified English nameCYHS2303334 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2023/12/02Generic · Class 3 | Indocyaninegreen for InjectionCYHS2303332 | Hainan Tian Sheng Bao He Bio Technology Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanized |
| 2023/12/02New drug · Class 2.2 | 派安普利单抗注射液 · No verified English nameCXSS2300089 | Zheng Da Tian Qing Kang Fang (Shanghai) Biopharmaceuticals Technology Co., Ltd. romanized; Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2023/12/02New drug · Class 2.2 | 葡萄糖口服溶液 · No verified English nameCXHS2300109 | Guo Ren Health Pharmaceutical (Beijing) Co., Ltd. romanized; Hunan Jia Heng Pharmaceutical Co., Ltd. romanized |
| 2023/12/02New drug · Class 2.2 | SXF-103口溶膜 · No verified English nameCXHL2301331 | Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized |
| 2023/12/01Import · Class 1 | 注射用Zetomipzomib · No verified English nameJXHL2300296 | Kezar Life Sciences Inc.; Everest Medicines (China) Co. Ltd. |
| 2023/12/01Generic · Class 3 | Ozagrel Sodium InjectionCYHS2303328 | Liaoning Hai Shen Lian Sheng Pharmaceutical Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2023/12/01Generic · Class 3 | Indobufen TabletsCYHS2303321 | Shanxi De Yuan Tang Pharma Co., Ltd. romanized |
| 2023/12/01New drug · Class 1 | LAE102注射液 · No verified English nameCXSL2300836 | Lai Kai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/12/01New drug · Class 1 | 注射用DB-1303 · No verified English nameCXSL2300835 | Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2023/12/01New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2300834 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2023/12/01New drug · Class 1 | 注射用ZL-1310 · No verified English nameCXSL2300833 | Zai Ding Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2023/12/01New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSL2300832 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2023/12/01New drug · Class 1 | 注射用SHR-A1921 · No verified English nameCXSL2300831 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2023/12/01New drug · Class 1 | 注射用菲泽妥单抗 · No verified English nameCXSL2300830 | Tian Jing Bio Technology (Shanghai) Co., Ltd. romanized |
| 2023/12/01New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2300829 | Li Zhu Group Xin Bei Jiang Pharmaceutical Co., Ltd. romanized |
| 2023/12/01New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2300828 | Li Zhu Group Xin Bei Jiang Pharmaceutical Co., Ltd. romanized |
| 2023/12/01New drug · Class 2.2 | KEM2105缓释片 · No verified English nameCXHL2301330 | Changsha Jing Yi Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/12/01New drug · Class 1 | HRS2398片 · No verified English nameCXHL2301329 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/12/01New drug · Class 1 | HRS2398片 · No verified English nameCXHL2301328 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/12/01New drug · Class 1 | CPU-216片 · No verified English nameCXHL2301327 | Zhongguo Yao Ke University romanized; Nanjing Qin Ling Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/12/01New drug · Class 1 | HRS-1167片 · No verified English nameCXHL2301326 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/12/01New drug · Class 1 | HRS-1167片 · No verified English nameCXHL2301325 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/12/01New drug · Class 1 | HRS-1167片 · No verified English nameCXHL2301324 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/11/30Import · Class 1 | ALXN1850注射液 · No verified English nameJXSL2300215 | Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd. |
73 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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