YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 291 drug applications between 16 July 2023 and 22 July 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 55, covering 42 drug names.
2023/07/16 – 2023/07/22
- New acceptances this week
- 291
- Drugs with new generic filings (by drug name, de-duplicated)
- 42
- 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
291filings, 55 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 139 |
| Generic | 55 |
| New drug | 54 |
| Import | 27 |
| Unspecified | 10 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 189 |
| Therapeutic biologic | 51 |
| TCM | 47 |
| 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
42 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Dapoxetine Hydrochloride Tablets | 3 | 2 | 20 |
| 2 | Ceftazidime And Avibactam Sodium For Injection | 2 | 2 | 12 |
| 3 | Ethyl Iosapentate Capsules | 2 | 1 | 27 |
| 4 | Piracetam Injection | 2 | 1 | 9 |
| 5 | Indobufen Tablets | 2 | 1 | 6 |
| 6 | Procaterol Hydrochloride Solution for Inhalation | 2 | 1 | 2 |
| 7 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 8 | Pravastatin Sodium Tablets | 2 | 1 | 2 |
| 9 | 注射用头孢唑肟钠 · No verified English name | 2 | 1 | 4 |
| 10 | Minoxidil Liniment | 2 | 1 | 52 |
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
179 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Sichuan He Li Xin Jian Pharma Co., Ltd. romanized | 13 | 13 | 0 |
| 2 | AstraZeneca AB | 8 | 4 | 0 |
| 3 | Chengdu Di Yi Pharmaceutical Co., Ltd. romanized | 7 | 3 | 1 |
| 4 | Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized | 6 | 5 | 0 |
| 5 | Bristol-Myers Squibb Company | 6 | 2 | 0 |
| 6 | Bo Rui Xin Chuang Biopharmaceuticals Technology (Wuxi) Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | Takeda Development Center Americas Inc. | 5 | 2 | 0 |
| 8 | Hainan Tong Yong San Yang Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 9 | Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized | 4 | 3 | 0 |
| 10 | Guangxi Xiu Zheng Pharmaceutical Co., Ltd. romanized | 4 | 3 | 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
99 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/07/22Import · Class 1 | Bemarituzumab注射液 · No verified English nameJXSL2300138 | Amgen Inc.; Zai Lab (Shanghai) CO. Ltd. |
| 2023/07/22Import · Class 1 | Cetrelimab注射液 · No verified English nameJXSL2300137 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/07/22Import · Class 1 | Cetrelimab注射液 · No verified English nameJXSL2300136 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/07/22Import · Class 2.2 | Anifrolumab注射液 · No verified English nameJXSL2300135 | AstraZeneca AB; AstraZeneca Investment (China)Co. Ltd |
| 2023/07/22Import · Class 1 | Forimtamig · No verified English nameJXSL2300134 | F. Hoffmann-La Roche Ltd; Roche R&D Center (China) Ltd. |
| 2023/07/22Import · Class 1 | Forimtamig · No verified English nameJXSL2300133 | F. Hoffmann-La Roche Ltd; Roche R&D Center (China) Ltd. |
| 2023/07/22Import · Class 1 | VAY736注射液 · No verified English nameJXSL2300132 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2023/07/22Import · Class 1 | BMS-986278-01片 · No verified English nameJXHL2300175 | Bristol-Myers Squibb Company; Bristol-Myers Squibb(China)Investment Co. Ltd |
| 2023/07/22Import · Class 1 | BMS-986278-01片 · No verified English nameJXHL2300174 | Bristol-Myers Squibb Company; Bristol-Myers Squibb(China)Investment Co. Ltd |
| 2023/07/22Import · Class 1 | BMS-986278-01片 · No verified English nameJXHL2300173 | Bristol-Myers Squibb Company; Bristol-Myers Squibb(China)Investment Co. Ltd |
| 2023/07/22Generic · Class 3 | 磷酸奥司他韦颗粒 · No verified English nameCYHS2301973 | Chengdu Di Yi Pharmaceutical Co., Ltd. romanized |
| 2023/07/22Generic · Class 3 | Acetylcysteine InjectionCYHS2301972 | Haikou Tian Xing Jian Drug Research Co., Ltd. romanized; Hainan Ai Ke Pharmaceutical Co., Ltd. romanized |
| 2023/07/22Generic · Class 3 | Betamethasone Sodium Phosphate InjectionCYHS2301970 | Hui Yu Yuan He (Hainan) Pharma Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2023/07/22New drug · Class 3.4 | 重组人II型肿瘤坏死因子受体-抗体融合蛋白注射液 · No verified English nameCXSS2300056 | Hangzhou Bo Zhi Rui Biopharmaceutical Co., Ltd. romanized |
| 2023/07/22New drug · Class 3.4 | 重组人II型肿瘤坏死因子受体-抗体融合蛋白注射液 · No verified English nameCXSS2300055 | Hangzhou Bo Zhi Rui Biopharmaceutical Co., Ltd. romanized |
| 2023/07/22New drug · Class 1 | NWRD08裸质粒DNA注射液 · No verified English nameCXSL2300507 | Nuo Wei Bio Technology (Wuxi) Co., Ltd. romanized; Nuo Wei Technology (Beijing) Co., Ltd. romanized |
| 2023/07/22New drug · Class 1 | JYB1931注射液 · No verified English nameCXSL2300506 | Jiangsu Ji Ye Biopharmaceutical Co., Ltd. romanized |
| 2023/07/22New drug · Class 1 | TQ05105片 · No verified English nameCXHL2300809 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/07/22New drug · Class 1 | TQB3909片 · No verified English nameCXHL2300808 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2023/07/21Import · Class 1 | BMS-986278-01片 · No verified English nameJXHL2300172 | Bristol-Myers Squibb Company; Bristol-Myers Squibb(China)Investment Co. Ltd |
| 2023/07/21Generic · Class 3 | Loxoprofen Sodium Oral SolutionCYHS2301966 | Yunnan Xian Shi Pharma Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2023/07/21Generic · Class 3 | 米诺地尔泡沫剂 · No verified English nameCYHS2301965 | Chen Guang (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2023/07/21Generic · Class 3 | 米诺地尔泡沫剂 · No verified English nameCYHS2301964 | Chen Guang (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2023/07/21Generic · Class 3 | Oxacillin Sodium for InjectionCYHS2301954 | Shandong Lan Jing Bio Technology Co., Ltd. romanized; Shandong Rui Ying Pharmaceutical Group Co., Ltd. romanized |
| 2023/07/21New drug · Class 1 | IMD101注射液 · No verified English nameCXSL2300505 | Shanghai Ying Mai De Medical Technology Co., Ltd. romanized |
| 2023/07/21New drug · Class 1 | IMD101注射液 · No verified English nameCXSL2300504 | Shanghai Ying Mai De Medical Technology Co., Ltd. romanized |
| 2023/07/21New drug · Class 1 | 人白介素-12注射液 · No verified English nameCXSL2300503 | Kang Li Tai Biopharmaceuticals (Qingdao) Co., Ltd. romanized |
| 2023/07/21New drug · Class 1 | 注射用重组人骨形态发生蛋白6 · No verified English nameCXSL2300502 | An Ji Sheng Biopharmaceuticals Technology (Guangzhou) Co., Ltd. romanized |
| 2023/07/21New drug · Class 1 | ELPIS人脐带间充质干细胞注射液 · No verified English nameCXSL2300501 | Hua Xia Yuan (Shanghai) Bio Technology Co., Ltd. romanized; Jiangxi Hua Xia Yuan Bio Technology Co., Ltd. romanized |
| 2023/07/21New drug · Class 1 | 苏帕鲁肽注射液 · No verified English nameCXSL2300500 | Shanghai Yin Nuo Biopharmaceuticals Gong Cheng Co., Ltd. romanized |
69 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.