YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 301 drug applications between 19 March 2025 and 25 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 77, covering 60 drug names.
2025/03/19 – 2025/03/25
- New acceptances this week
- 301
- Drugs with new generic filings (by drug name, de-duplicated)
- 60
- Accepted this week, now under review
- 23
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
301filings, 77 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 149 |
| Generic | 77 |
| New drug | 35 |
| Import | 23 |
| Unspecified | 10 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 205 |
| TCM | 45 |
| Therapeutic biologic | 45 |
| Prophylactic biologic | 6 |
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
60 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 4 | 2 | 60 |
| 2 | Progesterone Soft Capsules | 3 | 2 | 2 |
| 3 | Mupirocin Ointment | 3 | 1 | 30 |
| 4 | 氧(气态) · No verified English name | 2 | 2 | 1 |
| 5 | Sodium Iodide[131I] Oral Solution | 2 | 2 | 2 |
| 6 | Canagliflozin Tablets | 2 | 1 | 8 |
| 7 | Diclofenac Diethylamine Emulgel | 2 | 1 | 20 |
| 8 | Loxoprofen Sodium Patches | 2 | 1 | 30 |
| 9 | Buspirone Hydrochloride Tablets | 2 | 1 | 5 |
| 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
185 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Nei Menggu Fu Shou Tang Pharmaceutical Co., Ltd. romanized | 12 | 12 | 0 |
| 2 | Roche Pharma(Schweiz)AG | 8 | 1 | 0 |
| 3 | Amgen Inc. | 7 | 2 | 0 |
| 4 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized | 6 | 3 | 0 |
| 5 | Sanofi Winthrop Industrie | 6 | 1 | 0 |
| 6 | Hubei Wu Shi Pharma Co., Ltd. romanized | 5 | 3 | 5 |
| 7 | Sichuan Kelun Pharmaceutical Co., Ltd. | 5 | 1 | 0 |
| 8 | Li Bang Pharma (Shanghai) Co., Ltd. romanized | 5 | 1 | 0 |
| 9 | Xian Da Heng Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Celgene Corporation | 4 | 1 | 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
88 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/03/25Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSL2500043 | Merck Sharp & Dohme LLC; MSD R&D(China) Co. Ltd |
| 2025/03/25Import · Class 1 | AZD2936 · No verified English nameJXSL2500042 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/03/25Import · Class 2.2 | Tarlatamab · No verified English nameJXSL2500041 | Amgen Inc.; BeiGene (Beijing) Co. Ltd |
| 2025/03/25Import · Class 2.2 | Tarlatamab · No verified English nameJXSL2500040 | Amgen Inc.; BeiGene (Beijing) Co. Ltd |
| 2025/03/25Import · Class 2.2 | Tarlatamab · No verified English nameJXSL2500039 | Amgen Inc.; BeiGene (Beijing) Co. Ltd |
| 2025/03/25Generic · Class 3 | Hydrotalcite SuspensionCYHS2501173 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2025/03/25Generic · Class 3 | 盐酸精氨酸注射液 · No verified English nameCYHS2501162 | Sichuan Miao Ji Biopharmaceuticals Technology Co., Ltd. romanized; Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized |
| 2025/03/25Generic · Class 3 | Sodium Bicarbonate InjectionCYHS2501161 | Anhui Shuang He Pharma Co., Ltd. romanized |
| 2025/03/25Generic · Class 3 | Indocyaninegreen for InjectionCYHS2501160 | Ren He Yi Kang Hui Ze Pharma Hebei Co., Ltd. romanized |
| 2025/03/25Generic · Class 3 | Sodium Nitroprusside InjectionCYHS2501159 | Hainan Hai He Pharmaceutical Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized |
| 2025/03/25Generic · Class 3 | Bilastine Oral SolutionCYHS2501158 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2025/03/25Generic · Class 3 | Buspirone Hydrochloride TabletsCYHS2501157 | ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
| 2025/03/25Generic · Class 3 | Buspirone Hydrochloride TabletsCYHS2501156 | ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
| 2025/03/25Generic · Class 3 | 山梨醇甘露醇冲洗剂 · No verified English nameCYHS2501155 | Xian Jing Xi Shuang He Pharma Co., Ltd. romanized |
| 2025/03/25Generic · Class 3 | 双氯芬酸依泊胺贴 · No verified English nameCYHL2500065 | Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized |
| 2025/03/25New drug · Class 3.4 | 破伤风人免疫球蛋白 · No verified English nameCXSS2500038 | Zhejiang Hai Kang Bio Zhi Pin Co., Ltd. romanized |
| 2025/03/25New drug · Class 2.2 | 注射用MK-2870 · No verified English nameCXSL2500244 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2025/03/25New drug · Class 3.3 | 流感病毒裂解疫苗 · No verified English nameCXSL2500243 | Shaanxi Kun Qin Bio Technology Co., Ltd. romanized |
| 2025/03/25New drug · Class 1 | AZD0901 · No verified English nameCXSL2500242 | A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized |
| 2025/03/25New drug · Class 1 | 注射用TQB2102 · No verified English nameCXSL2500241 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2025/03/25New drug · Class 2.4 | 注射用甲苯磺酸瑞马唑仑 · No verified English nameCXHL2500317 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 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 |
58 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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