YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 316 drug applications between 14 October 2023 and 20 October 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 68, covering 48 drug names.
2023/10/14 – 2023/10/20
- New acceptances this week
- 316
- Drugs with new generic filings (by drug name, de-duplicated)
- 48
- Accepted this week, now under review
- 3
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
316filings, 68 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 175 |
| Generic | 68 |
| New drug | 46 |
| Import | 17 |
| Unspecified | 6 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 200 |
| TCM | 74 |
| Therapeutic biologic | 38 |
| Prophylactic biologic | 3 |
| 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
48 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 小儿复方氨基酸注射液(19AA-I) · No verified English name | 3 | 1 | 2 |
| 2 | Ixazomib Citrate Capsules | 3 | 1 | 7 |
| 3 | Oseltamivir Phosphate For Oral Suspension | 3 | 1 | 2 |
| 4 | Ezetimibe Tablets | 2 | 2 | 4 |
| 5 | Lidocaine and Prilocaine Cream | 2 | 2 | 24 |
| 6 | Timolol Maleate Eye Drops | 2 | 2 | 4 |
| 7 | Ambroxol Hydrochloride Solution For Inhalation | 2 | 1 | 10 |
| 8 | Diquafosol Sodium Eye Drops | 2 | 1 | 5 |
| 9 | Candesartan Cilexetil and Hydrochlorothiazide Tablets | 2 | 1 | 0 |
| 10 | 复方电解质醋酸钠葡萄糖注射液 · No verified English name | 2 | 1 | 22 |
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
192 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized | 16 | 15 | 0 |
| 2 | Hainan Pu Li Pharmaceutical Co., Ltd. romanized | 9 | 1 | 0 |
| 3 | Shang Qiu Shi Xin Ma Bio Technology Co., Ltd. romanized | 4 | 4 | 0 |
| 4 | Guangxi Hong Ji Pharma Group Co., Ltd. romanized | 4 | 4 | 0 |
| 5 | Shaanxi Nian Qing Bao Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Pfizer Europe MA EEIG | 4 | 3 | 0 |
| 7 | Ji Li De (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized | 4 | 2 | 0 |
| 8 | Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | 4 | 2 | 4 |
| 9 | JANSSEN-CILAG NV | 4 | 1 | 0 |
| 10 | Changchun Jin Sai Pharma Co., Ltd. romanized | 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
90 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/10/20Import · Class 1 | TAK-279片 · No verified English nameJXHL2300262 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd |
| 2023/10/20Import · Class 1 | TNO155 胶囊 · No verified English nameJXHL2300261 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2023/10/20Import · Class 1 | TNO155 胶囊 · No verified English nameJXHL2300260 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2023/10/20Import · Class 2.4 | Atogepant Tablets · No verified English nameJXHL2300259 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2023/10/20Generic · Class 3 | Carbazochrome Sodium Sulfonate InjectionCYHS2302818 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.; Hangzhou Minsheng Pharmaceutical Co., Ltd |
| 2023/10/20Generic · Class 3 | Magnesium Sulfate InjectionCYHS2302817 | Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2023/10/20Generic · Class 3 | Candesartan Cilexetil and Hydrochlorothiazide TabletsCYHS2302816 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2023/10/20Generic · Class 3 | Candesartan Cilexetil and Hydrochlorothiazide TabletsCYHS2302815 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2023/10/20Generic · Class 3 | 醋酸钠林格葡萄糖注射液 · No verified English nameCYHS2302812 | Chengdu Sai Nuo Lian Chuang Bio Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2023/10/20Generic · Class 3 | Multiple Electrolyte Additive For InjectionCYHS2302809 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2023/10/20New drug · Class 1 | 注射用AMT-707 · No verified English nameCXSL2300719 | Pu Zhong Fa Xian Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/10/20New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2300718 | Shanghai Lai Fu Medical Technology Co., Ltd. romanized |
| 2023/10/20New drug · Class 1 | 注射用FZ-AD005抗体偶联剂 · No verified English nameCXSL2300717 | Shanghai Fu Dan Zhang Jiang Biopharmaceuticals Co., Ltd. romanized |
| 2023/10/20New drug · Class 2.4 | Docetaxel InjectionCXHL2301134 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/10/20New drug · Class 1 | TQB3720片 · No verified English nameCXHL2301133 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2023/10/20New drug · Class 1 | RN0191注射液 · No verified English nameCXHL2301132 | Da Rui Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/10/20New drug · Class 1 | EG017软膏 · No verified English nameCXHL2301131 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2023/10/20New drug · Class 1 | EG017软膏 · No verified English nameCXHL2301130 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2023/10/20New drug · Class 1 | EG017软膏 · No verified English nameCXHL2301129 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2023/10/20New drug · Class 1 | EG017软膏 · No verified English nameCXHL2301128 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2023/10/20New drug · Class 1 | TRD205片 · No verified English nameCXHL2301127 | Beijing Tai De Pharmaceutical Co., Ltd. romanized |
| 2023/10/20New drug · Class 1 | TRD205片 · No verified English nameCXHL2301126 | Beijing Tai De Pharmaceutical Co., Ltd. romanized |
| 2023/10/19Import · Class 2.1 | Guselkumab Final Vialed Product for Intravenous Infusion (FVP(IV)) · No verified English nameJXSL2300187 | Janssen-Cilag International NV; Xian Janssen Pharmaceutical Ltd. |
| 2023/10/19Import · Class 2.1 | Guselkumab Final Vialed Product for Intravenous Infusion (FVP(IV)) · No verified English nameJXSL2300186 | Janssen-Cilag International NV; Xian Janssen Pharmaceutical Ltd. |
| 2023/10/19Import · Class 1 | LY3537982胶囊 · No verified English nameJXHL2300258 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/10/19Import · Class 1 | LY3537982胶囊 · No verified English nameJXHL2300257 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/10/19Import · Class 1 | RZL-012注射液 · No verified English nameJXHL2300256 | Raziel Therapeutics (RT) Ltd.; Tianjin Juvestar Biotech Co. Ltd. |
| 2023/10/19Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2302807 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2023/10/19Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2302806 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2023/10/19Generic · Class 3 | Ambroxol Hydrochloride Solution For InhalationCYHS2302805 | Rui Yang Pharmaceutical Co., Ltd. romanized |
60 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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