YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 304 drug applications between 28 June 2025 and 4 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 74, covering 47 drug names.
2025/06/28 – 2025/07/04
- New acceptances this week
- 304
- Drugs with new generic filings (by drug name, de-duplicated)
- 47
- Accepted this week, now under review
- 45
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
304filings, 74 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 166 |
| Generic | 74 |
| New drug | 43 |
| Import | 14 |
| Import re-registration | 5 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 187 |
| TCM | 75 |
| Therapeutic biologic | 41 |
| Prophylactic 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
47 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Acetylcysteine Injection | 6 | 6 | 53 |
| 2 | 瑞维那新吸入溶液 · No verified English name | 5 | 5 | 53 |
| 3 | Oseltamivir Phosphate Capsules | 5 | 2 | 39 |
| 4 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 3 | 2 | 23 |
| 5 | Sacubitril Valsartan Sodium Tablets | 3 | 2 | 70 |
| 6 | Pregabalin Extended release Tablets | 3 | 1 | 13 |
| 7 | Cefazolin Sodium for Injection | 3 | 1 | 13 |
| 8 | 蒙脱石混悬液 · No verified English name | 2 | 2 | 31 |
| 9 | 蔗糖羟基氧化铁咀嚼片 · No verified English name | 2 | 2 | 0 |
| 10 | 帕拉米韦氯化钠注射液 · No verified English name | 2 | 1 | 17 |
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
187 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shanxi Hua Kang Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 2 | Guangxi Lai Bin Hu Lu Wa Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 3 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 6 | 5 | 0 |
| 4 | Heilongjiang Jun An Pharma Group Hong Xiang Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Topfond Pharmaceutical Co., Ltd. | 5 | 4 | 0 |
| 6 | Lanzhou Tai Bao Pharmaceutical Co., Ltd. romanized | 5 | 3 | 0 |
| 7 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 5 | 3 | 0 |
| 8 | Celgene Corporation | 5 | 1 | 0 |
| 9 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 4 | 3 | 0 |
| 10 | Shen Wei Pharma Group 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
86 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/07/04Import · Class 2.3 | 迈之灵片 · No verified English nameJXZL2500002 | Aescuven Pharma Deutschland GmbH & Co.KG; Shenzhen Xingyin Pharmaceutical Co. Ltd. |
| 2025/07/04Import · Class 2.3 | 迈之灵片 · No verified English nameJXZL2500001 | Aescuven Pharma Deutschland GmbH & Co. KG; Shenzhen Xingyin Pharmaceutical Co. Ltd. |
| 2025/07/04Import · Class 1 | Trontinemab注射液 · No verified English nameJXSL2500119 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2025/07/04Import · Class 1 | MK-7240注射液 · No verified English nameJXSL2500118 | Merck Sharp & Dohme LLC; Name not romanized |
| 2025/07/04Import · Class 1 | GSK3862995B注射液 · No verified English nameJXSL2500117 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Company Limited |
| 2025/07/04Import · Class 1 | TAK-360片 · No verified English nameJXHL2500158 | Takeda Development Center Americas Inc. |
| 2025/07/04Import · Class 1 | TAK-360片 · No verified English nameJXHL2500157 | Takeda Development Center Americas Inc. |
| 2025/07/04Import · Class 1 | TAK-360片 · No verified English nameJXHL2500156 | Takeda Development Center Americas Inc. |
| 2025/07/04Import · Class 1 | TAK-360片 · No verified English nameJXHL2500155 | Takeda Development Center Americas Inc. |
| 2025/07/04Import · Class 2.2; 2.4 | 阿布昔替尼口服混悬液 · No verified English nameJXHL2500154 | Pfizer Inc.; PFIZER (CHINA) RESEARCH & DEVELOPMENT CO. LTD. |
| 2025/07/04Generic · Class 3 | 枸橼酸西地那非口溶膜 · No verified English nameCYHS2502368 | Hong Yue Technology (Hu Zhou) Co., Ltd. romanized; Jiangsu He Chen Pharma Co., Ltd. romanized |
| 2025/07/04Generic · Class 3 | Calcium Gluconate in Sodium Chloride InjectionCYHS2502367 | Chongqing Yao Gu Pharmaceutical Co., Ltd. romanized; HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. |
| 2025/07/04Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2502365 | Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized |
| 2025/07/04Generic · Class 3 | 中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2502361 | Guangdong Ke Hong Pharma Co., Ltd. romanized |
| 2025/07/04New drug · Class 1 | SCTB14注射液 · No verified English nameCXSL2500538 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2025/07/04New drug · Class 1 | SCTB14注射液 · No verified English nameCXSL2500537 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2025/07/04New drug · Class 1 | SHR-1139注射液 · No verified English nameCXSL2500536 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/07/04New drug · Class 1 | IPM514注射液 · No verified English nameCXSL2500535 | Beijing Zhen Zhi Yi Xue Technology Co., Ltd. romanized |
| 2025/07/04New drug · Class 1 | 安瑞替尼胶囊 · No verified English nameCXHS2500070 | Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized; Beijing Yi Ling Bio Gong Cheng Technology Co., Ltd. romanized |
| 2025/07/04New drug · Class 2.1; 2.2 | 注射用KLA478 · No verified English nameCXHL2500645 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2025/07/04New drug · Class 2.1; 2.2 | 注射用KLA478 · No verified English nameCXHL2500644 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2025/07/04New drug · Class 1 | ST114注射液 · No verified English nameCXHL2500643 | Hangzhou Rui Ao Biopharmaceuticals Co., Ltd. romanized |
| 2025/07/04New drug · Class 1 | 注射用ST205 · No verified English nameCXHL2500642 | Hangzhou Rui Ao Biopharmaceuticals Co., Ltd. romanized |
| 2025/07/04New drug · Class 2.4 | 注射用胶原酶 · No verified English nameCXHL2500641 | Yuan Da Sheng Ming Ke Xue (An Shan) Co., Ltd. romanized |
| 2025/07/04New drug · Class 2.1; 2.4 | DA002口服溶液 · No verified English nameCXHL2500640 | Yuan Da Yi Xue Ying Yang Ke Xue (Wuhan) Co., Ltd. romanized |
| 2025/07/04New drug · Class 2.1; 2.4 | DA002口服溶液 · No verified English nameCXHL2500639 | Yuan Da Yi Xue Ying Yang Ke Xue (Wuhan) Co., Ltd. romanized |
| 2025/07/04New drug · Class 1 | P052注射液 · No verified English nameCXHL2500638 | Hui Sheng Biopharmaceutical Co., Ltd. romanized |
| 2025/07/04New drug · Class 1 | P052注射液 · No verified English nameCXHL2500637 | Hui Sheng Biopharmaceutical Co., Ltd. romanized |
| 2025/07/03Generic · Class 3 | Peramivir InjectionCYHS2502356 | Shandong Yi Kang Pharma Co., Ltd. romanized |
| 2025/07/03Generic · Class 3 | 注射用泮托拉唑钠(Ⅰ) · No verified English nameCYHS2502352 | Jiangsu Jiu Xu Pharma Co., Ltd. romanized |
56 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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