YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 404 drug applications between 30 December 2025 and 5 January 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 109, covering 75 drug names.
2025/12/30 – 2026/01/05
- New acceptances this week
- 404
- Drugs with new generic filings (by drug name, de-duplicated)
- 75
- Accepted this week, now under review
- 121
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
404filings, 109 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 164 |
| Generic | 109 |
| New drug | 104 |
| Import | 14 |
| Unspecified | 8 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 244 |
| TCM | 92 |
| Therapeutic biologic | 63 |
| Biologic | 4 |
| Prophylactic 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
75 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 | 依伏卡塞片 · No verified English name | 4 | 2 | 9 |
| 3 | Upadacitinib Sustained-release Tablets | 3 | 3 | 43 |
| 4 | Fluticasone Propionate Cream | 3 | 2 | 12 |
| 5 | Oseltamivir Phosphate Capsules | 3 | 2 | 39 |
| 6 | Tadalafil Tablets | 3 | 1 | 23 |
| 7 | Pregabalin Capsules | 3 | 1 | 12 |
| 8 | 二甲硅油乳剂 · No verified English name | 2 | 2 | 14 |
| 9 | 盐酸毛果芸香碱滴眼液 · No verified English name | 2 | 2 | 5 |
| 10 | 西甲硅油乳剂 · No verified English name | 2 | 2 | 3 |
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
225 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Nei Menggu Da Tang Pharma Co., Ltd. romanized | 33 | 31 | 0 |
| 2 | Sichuan Tian De Pharmaceutical Co., Ltd. romanized | 9 | 9 | 0 |
| 3 | Janssen-Cilag International NV | 8 | 1 | 0 |
| 4 | Guangdong Wan Nian Qing Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Heng Ji Pharmaceuticals (Shanghai) Co., Ltd. romanized | 6 | 1 | 0 |
| 6 | Nanjing Rui Chu Pharmaceuticals Co., Ltd. romanized | 5 | 2 | 0 |
| 7 | Beijing Foyou Pharma CO.,LTD | 4 | 4 | 3 |
| 8 | Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 4 | 4 | 4 |
| 9 | Shen Wei Pharma (Zhang Jia Kou) Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Janssen Research & Development LLC | 4 | 3 | 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
144 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/01/05Import · Class 2.1 | 仑卡奈单抗注射液(皮下注射) · No verified English nameJXSS2600001 | Eisai Inc.; Terumo Corporation Kofu Factory; Eisai China Inc. |
| 2026/01/05Import · Class 2.1 | 注射用贝林妥欧单抗(皮下注射) · No verified English nameJXSL2600001 | Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd. |
| 2026/01/05Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2600030 | Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized |
| 2026/01/05Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2600029 | Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized |
| 2026/01/05Generic · Class 3 | 复方匹可硫酸钠颗粒 · No verified English nameCYHS2600022 | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized |
| 2026/01/05Generic · Class 3 | Voglibose Orally Dispersing TabletsCYHS2600017 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Jin Zhou Ao Hong Pharma Co., Ltd. romanized |
| 2026/01/05Generic · Class 3 | Probucol TabletsCYHS2600014 | Beijing Foyou Pharma CO.,LTD |
| 2026/01/05Generic · Class 3 | 枸橼酸西地那非口溶膜 · No verified English nameCYHS2600013 | Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized; Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized |
| 2026/01/05Generic · Class 3 | 盐酸甲氧氯普胺口服溶液 · No verified English nameCYHS2600005 | Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Tong Da Pharma Co., Ltd. romanized |
| 2026/01/05New drug · Class 1 | 注射用HMPL-A580 · No verified English nameCXSL2600011 | He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/01/05New drug · Class 1 | CT0596 CAR T细胞注射液 · No verified English nameCXSL2600004 | You Kai Ze Biopharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/01/05New drug · Class 1 | CT0596 CAR T细胞注射液 · No verified English nameCXSL2600003 | You Kai Ze Biopharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/01/05New drug · Class 1 | 注射用IN30758 · No verified English nameCXSL2600002 | Ying Shi Bio Technology (Shenzhen) Co., Ltd. romanized |
| 2026/01/05New drug · Class 3.3 | 重组抗PD-1人源化单克隆抗体注射液 · No verified English nameCXSL2600001 | Fu Xing Han Lin (Chengdu) Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized |
| 2026/01/05New drug · Class 2.3 | 西格列他钠二甲双胍缓释片 · No verified English nameCXHL2600017 | Shenzhen Wei Xin Bio Technology Co., Ltd. romanized; Chengdu Wei Xin Pharma Co., Ltd. romanized |
| 2026/01/05New drug · Class 2.3 | 西格列他钠二甲双胍缓释片 · No verified English nameCXHL2600016 | Shenzhen Wei Xin Bio Technology Co., Ltd. romanized; Chengdu Wei Xin Pharma Co., Ltd. romanized |
| 2026/01/05New drug · Class 2.2 | CBT-009眼用乳液 · No verified English nameCXHL2600011 | Bo Kang Shi Yun Biopharmaceuticals Technology (Suzhou) Co., Ltd. romanized |
| 2026/01/05New drug · Class 2.4 | 注射用盐酸伊吡诺司他 · No verified English nameCXHL2600010 | Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized |
| 2026/01/05New drug · Class 1 | FH001片 · No verified English nameCXHL2600009 | Heng Ji Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/01/05New drug · Class 1 | FH001片 · No verified English nameCXHL2600008 | Heng Ji Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/01/05New drug · Class 1 | FH001片 · No verified English nameCXHL2600007 | Heng Ji Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/01/05New drug · Class 1 | FH001片 · No verified English nameCXHL2600006 | Heng Ji Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/01/05New drug · Class 1 | FH001片 · No verified English nameCXHL2600005 | Heng Ji Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/01/05New drug · Class 1 | FH001片 · No verified English nameCXHL2600004 | Heng Ji Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/01/05New drug · Class 1 | FXS0683片 · No verified English nameCXHL2600003 | Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized |
| 2026/01/05New drug · Class 1 | FXS0683片 · No verified English nameCXHL2600002 | Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized |
| 2026/01/05New drug · Class 1 | FXS0683片 · No verified English nameCXHL2600001 | Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized |
| 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. |
114 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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