YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 337 drug applications between 29 December 2025 and 4 January 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 83, covering 56 drug names.
2025/12/29 – 2026/01/04
- New acceptances this week
- 337
- Drugs with new generic filings (by drug name, de-duplicated)
- 56
- Accepted this week, now under review
- 89
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
337filings, 83 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 121 |
| New drug | 103 |
| Generic | 83 |
| Import | 16 |
| Unspecified | 8 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 204 |
| TCM | 72 |
| Therapeutic biologic | 57 |
| Prophylactic biologic | 3 |
| 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
56 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 瑞维那新吸入溶液 · No verified English name | 4 | 4 | 53 |
| 2 | Upadacitinib Sustained-release Tablets | 3 | 3 | 43 |
| 3 | Fluticasone Propionate Cream | 3 | 2 | 12 |
| 4 | Tadalafil Tablets | 3 | 1 | 23 |
| 5 | Pregabalin Capsules | 3 | 1 | 12 |
| 6 | 达普司他片 · No verified English name | 3 | 1 | 0 |
| 7 | 二甲硅油乳剂 · No verified English name | 2 | 2 | 14 |
| 8 | Ferrous Succinate Tablets | 2 | 2 | 20 |
| 9 | 盐酸毛果芸香碱滴眼液 · No verified English name | 2 | 2 | 5 |
| 10 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
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
197 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Nei Menggu Da Tang Pharma Co., Ltd. romanized | 28 | 26 | 0 |
| 2 | Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized | 6 | 1 | 0 |
| 3 | Chongqing Zhang Xin Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 4 | Nanjing Rui Chu Pharmaceuticals Co., Ltd. romanized | 5 | 2 | 0 |
| 5 | Dan Dong Pharma Group Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 4 | 4 | 4 |
| 7 | Novartis Pharma AG | 4 | 3 | 0 |
| 8 | Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized | 4 | 3 | 4 |
| 9 | Excella GmbH & Co. KG | 4 | 2 | 0 |
| 10 | Bristol-Myers Squibb Company | 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
142 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/01/04Import · Class 2.4 | 盐酸芬氟拉明口服溶液 · No verified English nameJXHL2600001 | UCB Pharma S.A.; UCB Trading (Shanghai) Co. Ltd |
| 2026/01/04Generic · Class 3 | 尿素[14C]胶囊 · No verified English nameCYHL2500237 | Shenzhen Shi Fu Rui Kang Technology Co., Ltd. romanized |
| 2026/01/04New drug · Class 1 | QLH2405注射液 · No verified English nameCXSL2600006 | Qilu Pharmaceutical Co., Ltd. |
| 2026/01/04New drug · Class 1.2 | Argo-3002 · No verified English nameCXSL2600005 | A Ge Na Biopharmaceutical Co., Ltd. romanized; Guangzhou Shi Rui Bo Bio Technology Co., Ltd. romanized |
| 2026/01/04New drug · Class 1 | OVV-01注射液 · No verified English nameCXSL2501188 | Shanghai Rong Rui Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/01/04New drug · Class 1 | OVV-01注射液(静脉) · No verified English nameCXSL2501187 | Shanghai Rong Rui Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/01/04New drug · Class 1 | 注射用YK012 · No verified English nameCXSL2501186 | Yi Ke Si Te (Beijing) Pharmaceuticals Technology Development Co., Ltd. romanized |
| 2026/01/04New drug · Class 1 | 注射用YK012 · No verified English nameCXSL2501185 | Yi Ke Si Te (Beijing) Pharmaceuticals Technology Development Co., Ltd. romanized |
| 2026/01/04New drug · Class 1 | DSL201注射液 · No verified English nameCXSL2501184 | Suzhou Xing He Di Sai Bio Technology Co., Ltd. romanized |
| 2026/01/04New drug · Class 1 | 人脐带间充质基质细胞注射液 · No verified English nameCXSL2501180 | Jing Dong Fang Zai Sheng Yi Xue Technology Co., Ltd. romanized |
| 2026/01/04New drug · Class 1 | FL115注射液(皮下注射) · No verified English nameCXSL2501179 | Suzhou Fu Rong Bio Technology Co., Ltd. romanized |
| 2026/01/04New drug · Class 2.4 | Dexamethasone Palmitate InjectionCXHS2500168 | Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized |
| 2026/01/04New drug · Class 2.2 | 盐酸尼卡地平控释片 · No verified English nameCXHL2501539 | Beijing Wu He Bo Ao Pharma Co., Ltd. romanized; Zhongguo Yi Xue Ke College Drug Research Institute romanized; Guangxi Wu He Bo Ao Pharma Co., Ltd. romanized |
| 2026/01/04New drug · Class 1 | HSK46575片 · No verified English nameCXHL2501538 | Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2026/01/04New drug · Class 1 | HSK46575片 · No verified English nameCXHL2501537 | Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2026/01/04New drug · Class 1 | HSK46575片 · No verified English nameCXHL2501536 | Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2026/01/04New drug · Class 1 | LDR2515注射液 · No verified English nameCXHL2501532 | Chengdu Xian Yan Bio Technology Co., Ltd. romanized |
| 2026/01/04New drug · Class 1 | WT-1108片 · No verified English nameCXHL2501531 | Hangzhou Wei Tan Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/01/04New drug · Class 1 | WT-1108片 · No verified English nameCXHL2501530 | Hangzhou Wei Tan Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/01/04New drug · Class 2.2 | KLA578-2贴剂 · No verified English nameCXHL2501529 | Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2026/01/04New drug · Class 2.2 | KLA578-2贴剂 · No verified English nameCXHL2501528 | Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2026/01/04New drug · Class 1 | ABP-745片 · No verified English nameCXHL2501525 | Hangzhou Xin Yuan Su Pharma Co., Ltd. romanized |
| 2026/01/01New drug · Class 1 | LM-168注射液 · No verified English nameCXSL2501178 | Li Xin Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/01/01New drug · Class 2.3 | 海博麦布阿托伐他汀钙片 · No verified English nameCXHL2501524 | Han Hui Pharmaceutical Co., Ltd. romanized |
| 2026/01/01New drug · Class 1 | SYN818片 · No verified English nameCXHL2501523 | Hangzhou Sheng Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/01/01New drug · Class 1 | SYN818片 · No verified English nameCXHL2501522 | Hangzhou Sheng Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/31Import · Class 2.2 | Nipocalimab注射液 · No verified English nameJXSL2500251 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2025/12/31Import · Class 1 | BHV-8000缓释片 · No verified English nameJXHL2500406 | Biohaven Therapeutics Ltd.; Hangzhou Highlightll Pharmaceutical Co. Ltd |
| 2025/12/31Import · Class 1 | BHV-8000缓释片 · No verified English nameJXHL2500405 | Biohaven Therapeutics Ltd.; Hangzhou Highlightll Pharmaceutical Co. Ltd |
| 2025/12/31Import · Class 2.4 | BMS-986510胶囊 · No verified English nameJXHL2500404 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
112 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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