YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 239 drug applications between 30 October 2022 and 5 November 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 44, covering 36 drug names.
2022/10/30 – 2022/11/05
- New acceptances this week
- 239
- Drugs with new generic filings (by drug name, de-duplicated)
- 36
- 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
239filings, 44 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 107 |
| Generic | 44 |
| New drug | 37 |
| Import | 29 |
| Import re-registration | 19 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 173 |
| Therapeutic biologic | 36 |
| TCM | 29 |
| Biologic | 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
36 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Pentoxifylline Injection | 2 | 2 | 3 |
| 2 | Piracetam Injection | 2 | 1 | 9 |
| 3 | Empagliflozin Tablets | 2 | 1 | 18 |
| 4 | Urapidil Hydrochloride Injection | 2 | 1 | 6 |
| 5 | 羟乙基淀粉130/0.4氯化钠注射液 · No verified English name | 2 | 1 | 0 |
| 6 | Sugammadex Sodium Injection | 2 | 1 | 6 |
| 7 | Esomeprazole Magnesium Enteric-Coated Capsules | 2 | 1 | 4 |
| 8 | Dapagliflozin Tablets | 2 | 1 | 84 |
| 9 | Fluticasone Propionate Nebuliser Suspension | 1 | 1 | 8 |
| 10 | Canagliflozin Tablets | 1 | 1 | 8 |
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
144 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized | 9 | 1 | 0 |
| 2 | Hainan Mei Lan Shi Ke Pharmaceutical Co., Ltd. romanized | 8 | 1 | 0 |
| 3 | Jilin Sheng Yi Pu Bio Technology Co., Ltd. romanized | 5 | 5 | 0 |
| 4 | Shandong Han Fang Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | 5 | 3 | 5 |
| 6 | Qilu Pharmaceutical Co., Ltd. | 5 | 3 | 2 |
| 7 | Annora Pharma Private Limited | 5 | 2 | 0 |
| 8 | AstraZeneca AB | 4 | 3 | 0 |
| 9 | Boehringer Ingelheim International GmbH | 4 | 2 | 0 |
| 10 | Sanofi-Aventis Recherche & Développement | 4 | 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
75 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/11/05Import · Class 1 | 注射用SAR443216 · No verified English nameJXSL2200195 | Sanofi-Aventis Recherche & Développement; SANOFI (CHINA) INVESTMENT CO. LTD |
| 2022/11/05Import · Class 1 | 注射用SAR443216 · No verified English nameJXSL2200194 | Sanofi-Aventis Recherche & Développement; SANOFI (CHINA) INVESTMENT CO. LTD |
| 2022/11/05Import · Class 1 | AZD2936 · No verified English nameJXSL2200193 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2022/11/05Import · Class 1 | VAY736注射液 · No verified English nameJXSL2200192 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2022/11/05Import · Class 1 | MEDI5752 · No verified English nameJXSL2200191 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2022/11/05Generic · Class 3 | Pentoxifylline InjectionCYHS2201898 | Anhui Heng Xing Pharmaceutical Co., Ltd. romanized |
| 2022/11/05Generic · Class 3 | Cetirizine Hydrochloride InjectionCYHS2201895 | Beijing Si Huan Ke Bao Pharma Co., Ltd. romanized; Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2022/11/05New drug · Class 2.2 | 注射用维迪西妥单抗 · No verified English nameCXSL2200559 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2022/11/04Import · Class 1 | Omecamtiv Mecarbil缓释片 · No verified English nameJXHS2200102 | Cytokinetics Incorporated; Patheon Inc.; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd |
| 2022/11/04Import · Class 1 | Omecamtiv Mecarbil缓释片 · No verified English nameJXHS2200101 | Cytokinetics Incorporated; Patheon Inc.; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd |
| 2022/11/04Import · Class 1 | Omecamtiv Mecarbil缓释片 · No verified English nameJXHS2200100 | Cytokinetics Incorporated; Patheon Inc.; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd |
| 2022/11/04Import · Class 2.2 | 诺西那生钠注射液 · No verified English nameJXHL2200330 | Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd |
| 2022/11/04Import · Class 2.2 | 诺西那生钠注射液 · No verified English nameJXHL2200329 | Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd |
| 2022/11/04Generic · Class 3 | Piperacillin Sodium for InjectionCYHS2201894 | Hebei Dong Sheng Ke Yu Pharmaceuticals Technology Co., Ltd. romanized; NORTH CHINA PHARMACEUTICAL COMPANY.LTD |
| 2022/11/04Generic · Class 3 | Esketamine Hydrochloride InjectionCYHS2201893 | Yangtze River Pharmaceutical Group Co., Ltd |
| 2022/11/04Generic · Class 3 | Sildenafil Sitrate For Oral SuspensionCYHS2201889 | Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2022/11/04Generic · Class 3 | Piracetam InjectionCYHS2201888 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2022/11/04Generic · Class 3 | Piracetam InjectionCYHS2201887 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2022/11/04New drug · Class 1 | PE0116注射液 · No verified English nameCXSL2200558 | Shanghai Huai Yue Bio Technology Co., Ltd. romanized |
| 2022/11/04New drug · Class 3.3 | 德谷门冬双胰岛素注射液 · No verified English nameCXSL2200557 | Dong Guan Shi Dong Yang Guang Bio Yao Research and Development Co., Ltd. romanized; Guangdong Dong Yang Guang Pharma Co., Ltd. romanized |
| 2022/11/04New drug · Class 2.4 | ASC10片 · No verified English nameCXHL2200867 | Ge Li Bio Technology (Hangzhou) Co., Ltd. romanized |
| 2022/11/04New drug · Class 2.4; 2.1 | ASC10片 · No verified English nameCXHL2200866 | Ge Li Bio Technology (Hangzhou) Co., Ltd. romanized |
| 2022/11/03Generic · Class 3 | Nimodipine Oral SolutionCYHS2201882 | Shanghai Ao Quan Biopharmaceuticals Technology Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2022/11/03New drug · Class 2.3 | 阿利沙坦酯氨氯地平片 · No verified English nameCXHS2200061 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2022/11/03New drug · Class 1 | BPI-452080 片 · No verified English nameCXHL2200865 | Bei Da Pharma Co., Ltd. romanized |
| 2022/11/03New drug · Class 1 | BPI-452080 片 · No verified English nameCXHL2200864 | Bei Da Pharma Co., Ltd. romanized |
| 2022/11/02Import · Class 2.4 | 亮丙瑞林注射乳剂 · No verified English nameJXHL2200328 | Foresee Pharmaceuticals Co. Ltd; Changchun GeneScience Pharmaceuticals Co. Ltd. |
| 2022/11/02Import · Class 2.2; 2.4 | CBT-001眼用乳液 · No verified English nameJXHL2200327 | Cloudbreak Therapeutics LLC; Cloudbreak Bio-Pharmaceutical Science and Technology(Guangzhou)Co. Ltd |
| 2022/11/02Import · Class 2.2; 2.4 | CBT-001眼用乳液 · No verified English nameJXHL2200326 | Cloudbreak Therapeutics LLC; Cloudbreak Bio-Pharmaceutical Science and Technology(Guangzhou)Co. Ltd |
| 2022/11/02Import · Class 1 | SAR443122 硬胶囊 · No verified English nameJXHL2200325 | Sanofi-Aventis Recherche & Développement |
45 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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