YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 274 drug applications between 2 November 2022 and 8 November 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 44, covering 36 drug names.
2022/11/02 – 2022/11/08
- New acceptances this week
- 274
- Drugs with new generic filings (by drug name, de-duplicated)
- 36
- 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
274filings, 44 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 149 |
| Generic | 44 |
| New drug | 35 |
| Import | 29 |
| Import re-registration | 9 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 183 |
| TCM | 52 |
| Therapeutic biologic | 37 |
| 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
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 | Sacubitril Valsartan Sodium Tablets | 2 | 1 | 70 |
| 5 | Rocuronium Bromide Injection | 2 | 1 | 1 |
| 6 | 羟乙基淀粉130/0.4氯化钠注射液 · No verified English name | 2 | 1 | 0 |
| 7 | Sugammadex Sodium Injection | 2 | 1 | 6 |
| 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
149 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Gansu Xin Min Hai Pharmaceutical Co., Ltd. romanized | 14 | 14 | 0 |
| 2 | Bo Zhou Ya Ying Pharmaceuticals Technology Co., Ltd. romanized | 10 | 9 | 0 |
| 3 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized | 9 | 1 | 0 |
| 4 | Hainan Mei Lan Shi Ke Pharmaceutical Co., Ltd. romanized | 8 | 1 | 0 |
| 5 | Jilin Sheng Yi Pu Bio Technology Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | 5 | 3 | 5 |
| 7 | Annora Pharma Private Limited | 5 | 2 | 0 |
| 8 | Guangxi Lian He Sheng Sheng Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Sanofi-Aventis Recherche & Développement | 4 | 2 | 0 |
| 10 | Tianjin Jin Yao Pharma Co., Ltd. romanized | 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
63 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/11/08Import · Class 1 | Tiragolumab注射液 · No verified English nameJXSL2200197 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd |
| 2022/11/08Import · Class 1 | RO7247669注射液 · No verified English nameJXSL2200196 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd |
| 2022/11/08Generic · Class 3 | Pentoxifylline InjectionCYHS2201903 | Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2022/11/08New drug · Class 1 | 欧司珀利单抗注射液 · No verified English nameCXSL2200564 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2022/11/08New drug · Class 1 | 舒非尼酮(SC1011)片 · No verified English nameCXHL2200876 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/11/08New drug · Class 1 | HZ-A-018胶囊 · No verified English nameCXHL2200875 | Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized |
| 2022/11/08New drug · Class 1 | HZ-A-018胶囊 · No verified English nameCXHL2200874 | Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized |
| 2022/11/08New drug · Class 1 | HZ-A-018胶囊 · No verified English nameCXHL2200873 | Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized |
| 2022/11/08New drug · Class 1 | HZ-A-018胶囊 · No verified English nameCXHL2200872 | Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized |
| 2022/11/08New drug · Class 1 | ZXBT-1158胶囊 · No verified English nameCXHL2200871 | Shenzhen Shi Zhen Xing Bei Te Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/11/08New drug · Class 1 | ZXBT-1158胶囊 · No verified English nameCXHL2200870 | Shenzhen Shi Zhen Xing Bei Te Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/11/08New drug · Class 1 | APG-5918片 · No verified English nameCXHL2200869 | Suzhou Ya Sheng Pharma Co., Ltd. romanized; Guangzhou Shun Jian Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/11/08New drug · Class 1 | APG-5918片 · No verified English nameCXHL2200868 | Suzhou Ya Sheng Pharma Co., Ltd. romanized; Guangzhou Shun Jian Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/11/07New drug · Class 1 | EMB-07注射液 · No verified English nameCXSL2200562 | An Mai Bio Technology (Suzhou) Co., Ltd. romanized |
| 2022/11/07New drug · Class 1 | HLX23 · No verified English nameCXSL2200561 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized |
| 2022/11/07New drug · Class 1 | 重组抗PD-1全人源单克隆抗体注射液 · No verified English nameCXSL2200560 | Shanghai Yun Yi Health Technology Development Co., Ltd. romanized |
| 2022/11/06Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2201901 | Jiangxi Yi You Pharma Co., Ltd. romanized; Jing Cheng Hui Yao Pharma Co., Ltd. romanized |
| 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 |
33 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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