YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 378 drug applications between 19 August 2023 and 25 August 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 86, covering 67 drug names.
2023/08/19 – 2023/08/25
- New acceptances this week
- 378
- Drugs with new generic filings (by drug name, de-duplicated)
- 67
- 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
378filings, 86 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 202 |
| Generic | 86 |
| New drug | 48 |
| Import | 22 |
| Unspecified | 11 |
| Import re-registration | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 261 |
| TCM | 72 |
| Therapeutic biologic | 35 |
| Biologic | 6 |
| 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
67 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Potassium Chloride Injection | 3 | 3 | 10 |
| 2 | Rivaroxaban Tablets | 3 | 1 | 3 |
| 3 | Tadalafil Tablets | 2 | 2 | 23 |
| 4 | Bisoprolol Fumarate and Amlodipine Besylate Tablets | 2 | 2 | 9 |
| 5 | Famotidine Injection | 2 | 2 | 8 |
| 6 | Lornoxicam for Injection | 2 | 2 | 2 |
| 7 | Bortezomib For Injection | 2 | 2 | 1 |
| 8 | Labetalol Hydrochloride Injection | 2 | 2 | 4 |
| 9 | 复方奥美拉唑干混悬剂 · No verified English name | 2 | 1 | 0 |
| 10 | Montelukast Sodium Chewable Tablets | 2 | 1 | 4 |
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
223 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized | 33 | 32 | 0 |
| 2 | Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized | 9 | 9 | 0 |
| 3 | Changsha Ai Bei Gao Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Hainan Si Da Pharmaceutical Co., Ltd. romanized | 6 | 2 | 0 |
| 5 | GE Healthcare AS | 6 | 1 | 0 |
| 6 | Sanofi Winthrop Industrie | 6 | 1 | 0 |
| 7 | AstraZeneca AB | 5 | 2 | 0 |
| 8 | Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized | 4 | 3 | 0 |
| 9 | Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized | 4 | 2 | 1 |
| 10 | Eli Lilly and Company | 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
116 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/08/25Import · Class 1 | AZD5335 · No verified English nameJXSL2300158 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/08/25Import · Class 1 | AZD5305 · No verified English nameJXHL2300200 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/08/25Import · Class 1 | AZD5305 · No verified English nameJXHL2300199 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/08/25Import · Class 1 | AZD5305 · No verified English nameJXHL2300198 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/08/25Import · Class 1 | AZD5305 · No verified English nameJXHL2300197 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/08/25Generic · Class 3 | 阿瑞匹坦注射液 · No verified English nameCYHS2302273 | Jiangsu Kang He Biopharmaceutical Co., Ltd. romanized |
| 2023/08/25Generic · Class 3 | Acetylcysteine InjectionCYHS2302272 | Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized |
| 2023/08/25Generic · Class 3 | 脑脊髓手术用灌流液 · No verified English nameCYHS2302269 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2023/08/25Generic · Class 3 | Minoxidil Topical SolutionCYHS2302268 | Jiangsu Rui Shi Bio Technology Co., Ltd. romanized; Jiangsu Ziyond Pharmaceutical Co., Ltd. |
| 2023/08/25Generic · Class 3 | Minoxidil Topical SolutionCYHS2302267 | Jiangsu Rui Shi Bio Technology Co., Ltd. romanized; Jiangsu Ziyond Pharmaceutical Co., Ltd. |
| 2023/08/25Generic · Class 3 | Florbetapir F-18 InjectionCYHS2302261 | Beijing Xin He Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Jiang Yuan An Di Ke Zheng Dian Zi Research Development Co., Ltd. romanized |
| 2023/08/25Generic · Class 3 | Levocarnitine TabletsCYHL2300107 | Liaoning Nuo Wei Nuo Pharmaceutical Co., Ltd. romanized |
| 2023/08/25Generic · Class 3 | 注射用乳糖酸克拉霉素 · No verified English nameCYHL2300106 | Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized |
| 2023/08/25New drug · Class 1 | ZX2021注射液 · No verified English nameCXSL2300575 | Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized |
| 2023/08/25New drug · Class 1 | ZX2021注射液 · No verified English nameCXSL2300574 | Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized |
| 2023/08/25New drug · Class 1 | EB070注射液 · No verified English nameCXSL2300573 | Beijing Dong Fang Bai Tai Bio Technology Co., Ltd. romanized; Beijing Jing Yi Tai Xiang Technology Development Co., Ltd. romanized |
| 2023/08/25New drug · Class 1 | CRTE7A2-01 TCR-T细胞注射液 · No verified English nameCXSL2300572 | Beijing Ke Rui Bio Technology Co., Ltd. romanized |
| 2023/08/25New drug · Class 3.4 | QL2111注射液 · No verified English nameCXSL2300571 | Qilu Pharmaceutical Co., Ltd. |
| 2023/08/25New drug · Class 1 | GH21胶囊 · No verified English nameCXHL2300914 | Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2023/08/25New drug · Class 1 | GH21胶囊 · No verified English nameCXHL2300913 | Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2023/08/25New drug · Class 1 | TB-B002D注射液 · No verified English nameCXHL2300912 | Shenzhen Shi Tu Wei An Chuang Technology Kai Fa Co., Ltd. romanized |
| 2023/08/25New drug · Class 1 | HS-10511片 · No verified English nameCXHL2300911 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/08/25New drug · Class 1 | HS-10511片 · No verified English nameCXHL2300910 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/08/25New drug · Class 1 | HS-10511片 · No verified English nameCXHL2300909 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
| 2023/08/24Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2302257 | Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized; Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized |
| 2023/08/24Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2302256 | Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/08/24New drug · Class 3.3 | 注射用重组人促卵泡激素 · No verified English nameCXSS2300070 | Beijing SL Pharmaceutical Co., Ltd. |
| 2023/08/24New drug · Class 2.2 | 痘苗病毒致炎兔皮提取物注射液 · No verified English nameCXSL2300570 | Wei Shi Pharma (Ru Gao) Co., Ltd. romanized |
| 2023/08/24New drug · Class 2.2 | 泽贝妥单抗注射液 · No verified English nameCXSL2300569 | Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized |
| 2023/08/24New drug · Class 2.2 | 泽贝妥单抗注射液 · No verified English nameCXSL2300568 | Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized |
86 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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