YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 361 drug applications between 17 July 2025 and 23 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 109, covering 79 drug names.
2025/07/17 – 2025/07/23
- New acceptances this week
- 361
- Drugs with new generic filings (by drug name, de-duplicated)
- 79
- Accepted this week, now under review
- 83
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
361filings, 109 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 150 |
| Generic | 109 |
| New drug | 57 |
| Import | 27 |
| Unspecified | 14 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 263 |
| TCM | 53 |
| Therapeutic biologic | 28 |
| Prophylactic biologic | 10 |
| 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 | Mirogabalin Besilate Tablets | 4 | 2 | 61 |
| 3 | Ruxolitinib Phosphate Tablets | 3 | 1 | 27 |
| 4 | Upadacitinib Sustained-release Tablets | 2 | 2 | 43 |
| 5 | Morinidazole and Sodium Chloride Injection | 2 | 2 | 9 |
| 6 | Bumetanide Injection | 2 | 2 | 13 |
| 7 | 甘油磷酸钠注射液 · No verified English name | 2 | 2 | 7 |
| 8 | 维生素B6注射液 · No verified English name | 2 | 2 | 10 |
| 9 | Ilaprazole Enteric-coated Tablets | 2 | 2 | 26 |
| 10 | 蔗糖羟基氧化铁咀嚼片 · No verified English name | 2 | 2 | 0 |
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
233 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Beijing Min Hai Bio Technology Co., Ltd. romanized | 6 | 5 | 0 |
| 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 |
|---|---|---|
| 2025/07/23Import · 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. |
| 2025/07/23Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500195 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/07/23Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500194 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/07/23Import · Class 2.4 | LNP023胶囊 · No verified English nameJXHL2500192 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/07/23Import · Class 1 | PKN605片 · No verified English nameJXHL2500191 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/07/23Generic · Class 3 | 复方聚乙二醇3350电解质散 · No verified English nameCYHS2502666 | Hong You Pharma (Hainan) Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2025/07/23Generic · Class 3 | Doxycycline Hyclate for InjectionCYHS2502665 | Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanized |
| 2025/07/23Generic · Class 3 | Doxycycline Hyclate for InjectionCYHS2502663 | Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanized |
| 2025/07/23Generic · Class 3 | 维生素K1片 · No verified English nameCYHS2502661 | Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized |
| 2025/07/23Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2502660 | Wuhan Tong Ji Zhong Wei Pharmaceuticals Co., Ltd. romanized; Wuhan Bin Hu Shuang He Pharma Co., Ltd. romanized |
| 2025/07/23Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2502659 | Wuhan Tong Ji Zhong Wei Pharmaceuticals Co., Ltd. romanized; Wuhan Bin Hu Shuang He Pharma Co., Ltd. romanized |
| 2025/07/23Generic · Class 3 | Candesartan Cilexetil and Hydrochlorothiazide TabletsCYHS2502656 | Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized; Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. |
| 2025/07/23Generic · Class 3 | 复方聚乙二醇(3350)电解质维C散 · No verified English nameCYHS2502655 | Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2025/07/23Generic · Class 3 | Sodium Nitroprusside InjectionCYHS2502646 | Yang Zhou Zhong Bao Pharma Co., Ltd. romanized |
| 2025/07/23New drug · Class 1 | 脐血单个核细胞注射液 · No verified English nameCXSL2500614 | Guangzhou Xi Di Bio Technology Co., Ltd. romanized |
| 2025/07/23New drug · Class 1 | SCTB14注射液 · No verified English nameCXSL2500613 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2025/07/23New drug · Class 1 | SCTB14注射液 · No verified English nameCXSL2500612 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2025/07/23New drug · Class 1 | KC1036片 · No verified English nameCXHL2500741 | Beijing Kang Chen Pharma Co., Ltd. romanized |
| 2025/07/23New drug · Class 1 | KC1036片 · No verified English nameCXHL2500740 | Beijing Kang Chen Pharma Co., Ltd. romanized |
| 2025/07/23New drug · Class 1 | HTMC0435片 · No verified English nameCXHL2500739 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2025/07/23New drug · Class 1 | HTMC0435片 · No verified English nameCXHL2500738 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2025/07/23New drug · Class 1 | HTMC0435片 · No verified English nameCXHL2500737 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2025/07/23New drug · Class 1 | HTMC0435片 · No verified English nameCXHL2500736 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2025/07/23New drug · Class 2.2 | HL017 · No verified English nameCXHL2500735 | Hui Li Pharma (Suzhou) Co., Ltd. romanized |
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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