YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 336 drug applications between 20 August 2025 and 26 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 90, covering 64 drug names.
2025/08/20 – 2025/08/26
- New acceptances this week
- 336
- Drugs with new generic filings (by drug name, de-duplicated)
- 64
- Accepted this week, now under review
- 93
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
336filings, 90 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 169 |
| Generic | 90 |
| New drug | 38 |
| Import | 29 |
| Unspecified | 5 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 235 |
| TCM | 55 |
| Therapeutic biologic | 41 |
| Biologic | 2 |
| Prophylactic biologic | 2 |
| Unspecified | 1 |
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
64 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sufentanil Citrate Injection | 4 | 1 | 0 |
| 2 | Fexofenadine Hydrochloride Tablets | 4 | 1 | 10 |
| 3 | Magnesium Sulfate Injection | 3 | 2 | 7 |
| 4 | Memantine Hydrochloride OD Tablets | 3 | 1 | 2 |
| 5 | Polidocanol Injection | 3 | 1 | 23 |
| 6 | Potassium Chloride Injection | 2 | 2 | 10 |
| 7 | Apalutamide Tablets | 2 | 2 | 18 |
| 8 | 利伐沙班口崩片 · No verified English name | 2 | 1 | 4 |
| 9 | Lidocaine and Tetracaine Cream | 2 | 1 | 2 |
| 10 | 左乙拉西坦微片 · No verified English name | 2 | 1 | 2 |
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
216 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Eli Lilly and Company | 19 | 2 | 0 |
| 2 | NAPP PHARMACEUTICALS LIMITED | 9 | 1 | 0 |
| 3 | CSPC OUYI PHARMACEUTICAL CO., LTD. | 6 | 5 | 5 |
| 4 | AstraZeneca AB | 6 | 4 | 0 |
| 5 | Changchun Jin Sai Pharma Co., Ltd. romanized | 5 | 4 | 1 |
| 6 | Janssen-Cilag International NV | 5 | 2 | 0 |
| 7 | Jiangsu En Hua Pharma Co., Ltd. romanized | 5 | 2 | 4 |
| 8 | Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc. | 4 | 1 | 0 |
| 9 | Sichuan Pharmaceutical Formulations Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Zhi En Bio Technology Co., Ltd. romanized | 4 | 1 | 4 |
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
106 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/08/26Import · Class 1 | AZD0486 · No verified English nameJXSL2500158 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/08/26Import · Class 1 | AZD0486 · No verified English nameJXSL2500157 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/08/26Generic · Class 3 | Fosfomycin Sodium For InjectionCYHS2503131 | Hui Yu Yuan He (Hainan) Pharma Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized |
| 2025/08/26Generic · Class 3 | Fosfomycin Sodium For InjectionCYHS2503130 | Hui Yu Yuan He (Hainan) Pharma Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized |
| 2025/08/26Generic · Class 3 | Lidocaine Hydrochloride InjectionCYHS2503129 | Shanxi Ming Yu Bio Technology Co., Ltd. romanized; Shandong Fang Ming Pharma Group Co., Ltd. romanized |
| 2025/08/26Generic · Class 3 | Sevelamer Carbonate Powder for oral suspensionCYHS2503127 | Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanized |
| 2025/08/26Generic · Class 3 | 右酮洛芬氨丁三醇口服溶液 · No verified English nameCYHS2503126 | Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Guangdong Zhong Sheng Pharma Co., Ltd. romanized |
| 2025/08/26Generic · Class 3 | Sulindac TabletsCYHS2503125 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized |
| 2025/08/26Generic · Class 3 | Vincriscristine Sulfate InjectionCYHS2503117 | Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized |
| 2025/08/26Generic · Class 3 | Simethicone Chewable TabletsCYHS2503116 | Zhejiang Yuan Li Jian Pharma Co., Ltd. romanized |
| 2025/08/26Generic · Class 3 | Lidocaine and Tetracaine CreamCYHL2500154 | Beijing Yi Cheng Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/08/26Generic · Class 3 | Lidocaine and Tetracaine CreamCYHL2500153 | Beijing Yi Cheng Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/08/26Generic · Class 3 | Sufentanil Citrate InjectionCYHL2500152 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2025/08/26Generic · Class 3 | Sufentanil Citrate InjectionCYHL2500151 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2025/08/26Generic · Class 3 | Sufentanil Citrate InjectionCYHL2500150 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2025/08/26Generic · Class 3 | Sufentanil Citrate InjectionCYHL2500149 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2025/08/26New drug · Class 1.1 | 痰火丸 · No verified English nameCXZL2500068 | Shanghai Kai Bao Pharma Co., Ltd. romanized |
| 2025/08/26New drug · Class 1 | HBW-012462片 · No verified English nameCXHL2500889 | Chengdu Hai Bo Wei Pharma Co., Ltd. romanized |
| 2025/08/26New drug · Class 1 | HBW-012462片 · No verified English nameCXHL2500888 | Chengdu Hai Bo Wei Pharma Co., Ltd. romanized |
| 2025/08/25Import · Class 1 | Brenipatide注射液 · No verified English nameJXHL2500237 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/08/25Import · Class 1 | Brenipatide注射液 · No verified English nameJXHL2500236 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/08/25Import · Class 1 | Brenipatide注射液 · No verified English nameJXHL2500235 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/08/25Import · Class 1 | Brenipatide注射液 · No verified English nameJXHL2500234 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/08/25Import · Class 1 | Brenipatide注射液 · No verified English nameJXHL2500233 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/08/25Import · Class 1 | Brenipatide注射液 · No verified English nameJXHL2500232 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/08/25Import · Class 1 | Brenipatide注射液 · No verified English nameJXHL2500231 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/08/25Import · Class 1 | Brenipatide注射液 · No verified English nameJXHL2500230 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/08/25Import · Class 2.4 | 英克司兰钠注射液 · No verified English nameJXHL2500229 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/08/25Generic · Class 3 | 左羟丙哌嗪口服溶液 · No verified English nameCYHS2503113 | Hefei Hua Wei Pharma Co., Ltd. romanized |
| 2025/08/25New drug · Class 1 | SBK008注射液 · No verified English nameCXHL2500887 | Chengdu Shi Bei Kang Biopharmaceuticals Technology Co., Ltd. romanized |
76 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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