YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 367 drug applications between 18 July 2025 and 24 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 111, covering 79 drug names.
2025/07/18 – 2025/07/24
- New acceptances this week
- 367
- Drugs with new generic filings (by drug name, de-duplicated)
- 79
- Accepted this week, now under review
- 86
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
367filings, 111 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 154 |
| Generic | 111 |
| New drug | 62 |
| Import | 22 |
| Unspecified | 12 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 270 |
| TCM | 54 |
| Therapeutic biologic | 29 |
| Biologic | 7 |
| Prophylactic biologic | 7 |
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
79 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Dapoxetine Hydrochloride Tablets | 4 | 2 | 20 |
| 2 | 苯磺酸左氨氯地平片 · No verified English name | 4 | 2 | 45 |
| 3 | Mirogabalin Besilate Tablets | 4 | 2 | 61 |
| 4 | Ruxolitinib Phosphate Tablets | 3 | 1 | 27 |
| 5 | Upadacitinib Sustained-release Tablets | 2 | 2 | 43 |
| 6 | Bumetanide Injection | 2 | 2 | 13 |
| 7 | 甘油磷酸钠注射液 · No verified English name | 2 | 2 | 7 |
| 8 | Bromhexine Hydrochloride Oral Solution | 2 | 2 | 22 |
| 9 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 10 | 维生素B6注射液 · No verified English name | 2 | 2 | 10 |
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
236 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shandong Er Ye Pharmaceutical Co., Ltd. romanized | 6 | 3 | 3 |
| 2 | Eli Lilly and Company | 6 | 1 | 0 |
| 3 | Ningbo Tian Yi Pharma Technology Co., Ltd. romanized | 5 | 5 | 5 |
| 4 | Changchun Hai Wai Pharmaceutical Group Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Henan Zhen Shi Bio Technology Co., Ltd. romanized | 5 | 2 | 0 |
| 6 | Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Revance Therapeutics Inc. | 4 | 4 | 0 |
| 8 | Zhu Zhou Qian Jin Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Guangdong Xiang Shan Tang Pharmaceutical Co., Ltd. romanized | 4 | 3 | 0 |
| 10 | Bristol-Myers Squibb Company | 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
116 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/07/24Import · Class 2.1 | ASP5541注射液 · No verified English nameJXHL2500200 | Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd. |
| 2025/07/24Generic · Class 3 | 盐酸丙卡特罗干糖浆 · No verified English nameCYHS2502690 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2025/07/24Generic · Class 3 | Ebastine Oral SolutionCYHS2502684 | Jiangsu Vanguard Pharmaceutical Co., Ltd. |
| 2025/07/24Generic · Class 3 | Pioglitazone and Metformin Hydrochloride TabletsCYHS2502679 | Henan Da Xin Pharma Co., Ltd. romanized |
| 2025/07/24Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2502677 | Hefei Yuan Zhi Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Anhui Xin Shi Ji Pharma Co., Ltd. romanized |
| 2025/07/24Generic · Class 3 | Erythromycin Lactobionate for InjectionCYHS2502675 | Hainan Yun Ding Pharmaceuticals Technology Co., Ltd. romanized; Haikou Qi Li Pharmaceutical Co., Ltd. romanized |
| 2025/07/24Generic · Class 3 | 盐酸多沙普仑注射液 · No verified English nameCYHS2502669 | Yang Zhou Zhong Bao Pharma Co., Ltd. romanized |
| 2025/07/24New drug · Class 1 | WSK-IM02 · No verified English nameCXSL2500615 | Beijing Wei Si Ke Biopharmaceuticals Co., Ltd. romanized; Chengdu Wei Si Ke Biopharmaceuticals Co., Ltd. romanized; Wei Si Ke Biopharmaceuticals (Guangzhou) Co., Ltd. romanized |
| 2025/07/24New drug · Class 2.4 | 甲磺酸伏美替尼片 · No verified English nameCXHS2500084 | Shanghai Ai Li Si Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Ai Li Si Biopharmaceuticals Co., Ltd. romanized |
| 2025/07/24New drug · Class 1 | 特里豚蝎肽凝胶 · No verified English nameCXHL2500755 | Wuhan Mo Er Bio Technology Co., Ltd. romanized |
| 2025/07/24New drug · Class 1 | TSL2109胶囊 · No verified English nameCXHL2500754 | Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized; Zhongguo Yao Ke University romanized |
| 2025/07/24New drug · Class 1 | TSL2109胶囊 · No verified English nameCXHL2500753 | Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized; Zhongguo Yao Ke University romanized |
| 2025/07/24New drug · Class 1 | LBS-007注射溶液 · No verified English nameCXHL2500752 | Beijing Xi Er Ou Biopharmaceuticals Kai Fa Co., Ltd. romanized |
| 2025/07/24New drug · Class 1 | HEP-50768片 · No verified English nameCXHL2500751 | Hai Pai Tai Ke (Beijing) Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/07/24New drug · Class 1 | HEP-50768片 · No verified English nameCXHL2500750 | Hai Pai Tai Ke (Beijing) Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/07/24New drug · Class 1 | HEP-50768片 · No verified English nameCXHL2500749 | Hai Pai Tai Ke (Beijing) Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/07/24New drug · Class 1 | HEP-50768片 · No verified English nameCXHL2500748 | Hai Pai Tai Ke (Beijing) Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/07/24New drug · Class 1 | BPR-6023021注射液 · No verified English nameCXHL2500747 | Chengdu Xin Ke Pharmaceuticals Co., Ltd. romanized |
| 2025/07/24New drug · Class 1 | 注射用ARTS-876 · No verified English nameCXHL2500746 | An Rui Biopharmaceuticals Technology (Guangzhou) Co., Ltd. romanized |
| 2025/07/24New drug · Class 1 | 埃诺格鲁肽片 · No verified English nameCXHL2500745 | Hangzhou Xian Wei Da Bio Technology Co., Ltd. romanized |
| 2025/07/24New drug · Class 1 | 埃诺格鲁肽片 · No verified English nameCXHL2500744 | Hangzhou Xian Wei Da Bio Technology Co., Ltd. romanized |
| 2025/07/24New drug · Class 1 | 埃诺格鲁肽片 · No verified English nameCXHL2500743 | Hangzhou Xian Wei Da Bio Technology Co., Ltd. romanized |
| 2025/07/24New drug · Class 1 | 埃诺格鲁肽片 · No verified English nameCXHL2500742 | Hangzhou Xian Wei Da Bio Technology Co., Ltd. romanized |
| 2025/07/23Import · Class 1 | Depemokimab注射液 · No verified English nameJXSL2500126 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd. |
| 2025/07/23Import · Class 1 | PF-08046054 (注射用冻干粉针) · No verified English nameJXSL2500125 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2025/07/23Import · Class 1 | BAY 2927088片 · No verified English nameJXHS2500077 | Bayer HealthCare Pharmaceuticals Inc.; Bayer AG; Bayer Healthcare Company Ltd. |
| 2025/07/23Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500199 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/07/23Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500198 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/07/23Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500197 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/07/23Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500196 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
86 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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