YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 400 drug applications between 29 July 2025 and 4 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 97, covering 74 drug names.
2025/07/29 – 2025/08/04
- New acceptances this week
- 400
- Drugs with new generic filings (by drug name, de-duplicated)
- 74
- Accepted this week, now under review
- 78
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
400filings, 97 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 193 |
| Generic | 97 |
| New drug | 63 |
| Import | 25 |
| Import re-registration | 16 |
| Unspecified | 4 |
| Drug-device combination product | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 248 |
| TCM | 87 |
| Therapeutic biologic | 59 |
| Unspecified | 3 |
| Prophylactic biologic | 2 |
| 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
74 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sacubitril Valsartan Sodium Tablets | 4 | 2 | 70 |
| 2 | Cefditoren Pivoxil Granules | 3 | 2 | 18 |
| 3 | Dapagliflozin Tablets | 3 | 2 | 84 |
| 4 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 5 | Omega-3-acid ethyl ester 90 Soft Capsules | 2 | 2 | 11 |
| 6 | Pemafibrate Tablets | 2 | 2 | 23 |
| 7 | 双氯芬酸钠盐酸利多卡因注射液 · No verified English name | 2 | 2 | 8 |
| 8 | 头孢克肟干混悬剂 · No verified English name | 2 | 2 | 3 |
| 9 | Trazodone Hydrochloride Sustained-release Tablets | 2 | 2 | 20 |
| 10 | 硝普钠氯化钠注射液 · No verified English name | 2 | 2 | 3 |
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
251 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Sichuan Kelun Pharmaceutical Co., Ltd. | 14 | 5 | 1 |
| 2 | Shanxi Hua Kang Pharma Co., Ltd. romanized | 10 | 9 | 0 |
| 3 | Qilu Pharmaceutical Co., Ltd. | 8 | 4 | 1 |
| 4 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 8 | 3 | 0 |
| 5 | Amgen Inc. | 6 | 3 | 0 |
| 6 | Novo Nordisk A/S | 6 | 2 | 0 |
| 7 | Henan Xin Xiang Hua Xing Pharmaceutical Factory romanized | 6 | 2 | 0 |
| 8 | AstraZeneca UK Limited | 6 | 1 | 0 |
| 9 | Changchun Hai Wai Pharmaceutical Group Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 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
107 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/08/04Generic · Class 3 | Polaprezinc GranulesCYHS2502808 | Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized; Guangdong An Nuo Pharma Co., Ltd. romanized |
| 2025/08/04Generic · Class 3 | Betamethasone Sodium Phosphate InjectionCYHS2502807 | Anhui Jun Da Gao Ke Pharmaceuticals Technology Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2025/08/04Generic · Class 3 | 中性腹膜透析液(乳酸盐-G2.5%) · No verified English nameCYHS2502806 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2025/08/04Generic · Class 3 | 中性低钙腹膜透析液(乳酸盐-G2.5%) · No verified English nameCYHS2502805 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2025/08/04Generic · Class 3 | Magnesium Sulfate InjectionCYHS2502804 | Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized |
| 2025/08/04Generic · Class 3 | Famotidine InjectionCYHS2502800 | Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized |
| 2025/08/04New drug · Class 1.2 | 杜仲木脂素胶囊 · No verified English nameCXZL2500061 | Jiangxi Pu Zheng Pharmaceutical Co., Ltd. romanized; Shanghai Xian Dai Drug Formulations Gong Cheng Research Center Co., Ltd. romanized |
| 2025/08/04New drug · Class 1.2 | 杜仲木脂素提取物 · No verified English nameCXZL2500060 | Jiangxi Pu Zheng Pharmaceutical Co., Ltd. romanized; Shanghai Xian Dai Drug Formulations Gong Cheng Research Center Co., Ltd. romanized |
| 2025/08/04New drug · Class 1 | FNX020片 · No verified English nameCXHL2500805 | Chengdu Fan Nuo Xi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/08/04New drug · Class 1 | FNX020片 · No verified English nameCXHL2500804 | Chengdu Fan Nuo Xi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/08/02Import · Class 2.1 | Onasemnogene abeparvovec鞘内注射液 · No verified English nameJXSS2500106 | Novartis Pharma Schweiz AG; Novartis Gene Therapies Inc.; Beijing Novartis Pharma Co. Ltd. |
| 2025/08/02Import · Class 1 | ABBV-400注射用粉末 · No verified English nameJXSL2500137 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2025/08/02Generic · Class 3 | 复方醋酸钠葡萄糖注射液 · No verified English nameCYHS2502797 | Sichuan Qi Yu Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2025/08/02Generic · Class 3 | 复方醋酸钠葡萄糖注射液 · No verified English nameCYHS2502796 | Sichuan Qi Yu Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2025/08/02Generic · Class 3 | Pioglitazone and Metformin Hydrochloride TabletsCYHS2502785 | Guangdong Fang Sheng Jian Meng Pharma Co., Ltd. romanized; Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized |
| 2025/08/02Generic · Class 3 | 维生素B??注射液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2502772 | Hainan Jun Hua Medical Technology Co., Ltd. romanized; Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized |
| 2025/08/02Generic · Class 3 | Relugolix TabletsCYHL2500136 | Guangdong Fang Sheng Jian Meng Pharma Co., Ltd. romanized |
| 2025/08/02New drug · Class 1.1 | 益气升脉颗粒 · No verified English nameCXZL2500059 | Rui Yang Pharmaceutical Co., Ltd. romanized |
| 2025/08/02New drug · Class 1 | VPD/FC01002 注射液 · No verified English nameCXSL2500652 | Wei Neng Sheng Ming Technology Group Co., Ltd. romanized |
| 2025/08/02New drug · Class 1 | VUM02注射液 · No verified English nameCXSL2500651 | Wuhan Guang Gu Zhong Yuan Pharma Co., Ltd. romanized |
| 2025/08/02New drug · Class 1 | HTB-C042鼻喷雾剂 · No verified English nameCXSL2500650 | Shanghai Hui Dun Yin Tai Bio Technology Co., Ltd. romanized; Shanghai Hui Dun Bio Technology Co., Ltd. romanized |
| 2025/08/02New drug · Class 1 | 注射用JSKN003 · No verified English nameCXSL2500649 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized |
| 2025/08/02New drug · Class 1 | 注射用JSKN022 · No verified English nameCXSL2500648 | Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized |
| 2025/08/02New drug · Class 1 | SNC115注射液 · No verified English nameCXSL2500647 | Shanghai Xian Bo Bio Technology Co., Ltd. romanized |
| 2025/08/02New drug · Class 1 | HS-20117-2 注射液 · No verified English nameCXSL2500646 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2025/08/02New drug · Class 1 | TQB2868注射液 · No verified English nameCXSL2500645 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2025/08/02New drug · Class 2.2 | 注射用瑞康曲妥珠单抗 · No verified English nameCXSL2500644 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/08/02New drug · Class 1 | 玛氘诺沙韦片 · No verified English nameCXHS2500089 | Jia Xing An Di Kang Bio Technology Co., Ltd. romanized; Shanghai He Quan Pharmaceuticals Co., Ltd. romanized |
| 2025/08/02New drug · Class 1 | APH03621片 · No verified English nameCXHL2500803 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized |
| 2025/08/02New drug · Class 1 | APH03621片 · No verified English nameCXHL2500802 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized |
77 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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