YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 308 drug applications between 18 March 2025 and 24 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 71, covering 55 drug names.
2025/03/18 – 2025/03/24
- New acceptances this week
- 308
- Drugs with new generic filings (by drug name, de-duplicated)
- 55
- Accepted this week, now under review
- 21
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
308filings, 71 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 159 |
| Generic | 71 |
| New drug | 44 |
| Import | 20 |
| Unspecified | 9 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 209 |
| TCM | 48 |
| Therapeutic biologic | 43 |
| Prophylactic biologic | 8 |
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
55 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Mupirocin Ointment | 3 | 1 | 30 |
| 2 | 氧(气态) · No verified English name | 2 | 2 | 1 |
| 3 | Sodium Iodide[131I] Oral Solution | 2 | 2 | 2 |
| 4 | Canagliflozin Tablets | 2 | 1 | 8 |
| 5 | Diclofenac Diethylamine Emulgel | 2 | 1 | 20 |
| 6 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 7 | Hydrocortisone Sodium Succinate for Injection | 2 | 1 | 16 |
| 8 | Loxoprofen Sodium Patches | 2 | 1 | 30 |
| 9 | Lidocaine Hydrochloride Injection | 2 | 1 | 6 |
| 10 | Bupivacaine Hydrochloride Injection | 2 | 1 | 4 |
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
183 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Nei Menggu Fu Shou Tang Pharmaceutical Co., Ltd. romanized | 11 | 11 | 0 |
| 2 | Roche Pharma (Schweiz) AG | 8 | 1 | 0 |
| 3 | Roche Pharma(Schweiz)AG | 8 | 1 | 0 |
| 4 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized | 6 | 3 | 0 |
| 5 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 5 | 3 | 0 |
| 6 | Sichuan Kelun Pharmaceutical Co., Ltd. | 5 | 1 | 0 |
| 7 | Li Bang Pharma (Shanghai) Co., Ltd. romanized | 5 | 1 | 0 |
| 8 | Hunan Jiudian Pharmaceutical Co., Ltd | 4 | 4 | 0 |
| 9 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Henan Pu Rui Pharma Co., Ltd. romanized | 4 | 2 | 4 |
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
94 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/03/24Import · Class 1 | Golcadomide胶囊 · No verified English nameJXHL2500055 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2025/03/24Import · Class 1 | Golcadomide胶囊 · No verified English nameJXHL2500054 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2025/03/24Import · Class 1 | Golcadomide胶囊 · No verified English nameJXHL2500053 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2025/03/24Import · Class 1 | Golcadomide胶囊 · No verified English nameJXHL2500052 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2025/03/24New drug · Class 1 | Alpha-0261片 · No verified English nameCXHL2500316 | Shenzhen A Er Fa Fen Zi Technology Co., Ltd. romanized |
| 2025/03/24New drug · Class 1 | Alpha-0261片 · No verified English nameCXHL2500315 | Shenzhen A Er Fa Fen Zi Technology Co., Ltd. romanized |
| 2025/03/22Import · Class 2.2 | 利妥昔单抗注射液 · No verified English nameJXSS2500036 | Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH |
| 2025/03/22Import · Class 2.2 | 利妥昔单抗注射液 · No verified English nameJXSS2500035 | Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH |
| 2025/03/22Import · Class 2.2 | 利妥昔单抗注射液 · No verified English nameJXSS2500034 | Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH |
| 2025/03/22Import · Class 2.2 | 利妥昔单抗注射液 · No verified English nameJXSS2500033 | Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH |
| 2025/03/22Import · Class 2.2 | 利妥昔单抗注射液 · No verified English nameJXSS2500032 | Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH |
| 2025/03/22Import · Class 2.2 | 利妥昔单抗注射液 · No verified English nameJXSS2500031 | Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH |
| 2025/03/22Import · Class 2.2 | 利妥昔单抗注射液 · No verified English nameJXSS2500030 | Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH |
| 2025/03/22Import · Class 2.2 | 利妥昔单抗注射液 · No verified English nameJXSS2500029 | Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH |
| 2025/03/22Import · Class 3.1 | 度伐利尤单抗注射液 · No verified English nameJXSS2500028 | AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2025/03/22Import · Class 3.1 | 度伐利尤单抗注射液 · No verified English nameJXSS2500027 | AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2025/03/22Import · Class 1 | MK-1084片 · No verified English nameJXHL2500051 | Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2025/03/22Import · Class 1 | MK-1084片 · No verified English nameJXHL2500050 | Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2025/03/22Generic · Class 3 | Colchicine TabletsCYHS2501148 | Yi Jia Pharma (Hubei) Co., Ltd. romanized; Zhejiang Zhe Bei Pharma Co., Ltd. romanized |
| 2025/03/22Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2501147 | Shanghai Xuan Xin Pharmaceuticals Technology Co., Ltd. romanized; Shandong Fang Ming Pharma Group Co., Ltd. romanized |
| 2025/03/22Generic · Class 3 | 酮洛芬凝胶贴膏 · No verified English nameCYHL2500064 | Beijing Yang Guang Nuo He Drug Research Co., Ltd. romanized |
| 2025/03/22New drug · Class 3.2 | 流感病毒裂解疫苗(BK-01佐剂) · No verified English nameCXSL2500240 | Changchun Bai Ke Bio Technology Shareholding Company romanized |
| 2025/03/22New drug · Class 3.2 | 流感病毒裂解疫苗(BK-01佐剂) · No verified English nameCXSL2500239 | Changchun Bai Ke Bio Technology Shareholding Company romanized |
| 2025/03/22New drug · Class 1 | GenSci134注射液 · No verified English nameCXSL2500238 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2025/03/22New drug · Class 1 | GenSci134注射液 · No verified English nameCXSL2500237 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2025/03/22New drug · Class 2.4 | CMCY2501片 · No verified English nameCXHL2500314 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2025/03/21Generic · Class 3 | Sodium Iodide[131I] Oral SolutionCYHS2501145 | Chengdu Xin Ke Pharmaceuticals Co., Ltd. romanized |
| 2025/03/21Generic · Class 3 | Acetazolamide TabletsCYHS2501142 | Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized |
| 2025/03/21New drug · Class 3.3 | 流感病毒裂解疫苗 · No verified English nameCXSS2500037 | Cheng Da Bio (Ben Xi) Co., Ltd. romanized |
| 2025/03/21New drug · Class 1 | BT02单克隆抗体注射液 · No verified English nameCXSL2500236 | Shanghai Bai Quan Bio Technology Co., Ltd. romanized |
64 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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