YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 556 drug applications between 25 February 2026 and 3 March 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 119, covering 89 drug names.
2026/02/25 – 2026/03/03
- New acceptances this week
- 556
- Drugs with new generic filings (by drug name, de-duplicated)
- 89
- Accepted this week, now under review
- 193
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
556filings, 119 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 242 |
| New drug | 135 |
| Generic | 119 |
| Import | 36 |
| Unspecified | 16 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 347 |
| Therapeutic biologic | 121 |
| TCM | 77 |
| Prophylactic biologic | 7 |
| Biologic | 3 |
| In vitro diagnostic reagent | 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
89 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Rosuvastatin Calcium Tablets | 4 | 2 | 18 |
| 2 | Cariprazine hydrochloride Capsules | 3 | 1 | 3 |
| 3 | Fluocinolone Acetonide,Hydroquinone And Tretinoin Cream | 2 | 2 | 1 |
| 4 | 注射用甲苯磺酸奥马环素 · No verified English name | 2 | 2 | 9 |
| 5 | 盐酸氮?斯汀滴眼液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified. | 2 | 2 | 6 |
| 6 | Iguratimod Tablets | 2 | 2 | 23 |
| 7 | Tadalafil Tablets | 2 | 1 | 23 |
| 8 | Eplerenone Tablets | 2 | 1 | 4 |
| 9 | Diclofenac Sodium Sustained Release Tablets | 2 | 1 | 10 |
| 10 | Dotinurad Tablets | 2 | 1 | 55 |
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
317 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 9 | 6 | 0 |
| 2 | Amgen Inc. | 9 | 3 | 0 |
| 3 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized | 7 | 4 | 0 |
| 4 | Novartis Pharma AG | 7 | 3 | 0 |
| 5 | The Wellcome Foundation Limited | 7 | 2 | 0 |
| 6 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 6 | 6 | 0 |
| 7 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized | 6 | 4 | 0 |
| 8 | Qilu Pharmaceutical Co., Ltd. | 6 | 4 | 0 |
| 9 | Takeda Development Center Americas Inc. | 6 | 2 | 0 |
| 10 | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized | 6 | 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
212 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/03/03Import · Class 3.1 | 司美格鲁肽注射液 · No verified English nameJXSS2600019 | Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd |
| 2026/03/03Import · Class 3.1 | 司美格鲁肽注射液 · No verified English nameJXSS2600018 | Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd |
| 2026/03/03Import · Class 3.1 | 司美格鲁肽注射液 · No verified English nameJXSS2600017 | Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd |
| 2026/03/03Import · Class 3.1 | 司美格鲁肽注射液 · No verified English nameJXSS2600016 | Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd |
| 2026/03/03Import · Class 3.1 | 司美格鲁肽注射液 · No verified English nameJXSS2600015 | Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd |
| 2026/03/03Import · Class 3.1 | 来瑞奇珠单抗注射液 · No verified English nameJXSS2600014 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2026/03/03New drug · Class 1 | GA002注射液 · No verified English nameCXSL2600299 | Jian Da Jiu Zhou (Beijing) Bio Technology Co., Ltd. romanized |
| 2026/03/03New drug · Class 1 | 注射用BAT8013 · No verified English nameCXSL2600298 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2026/03/03New drug · Class 1 | 注射用BR111 · No verified English nameCXSL2600295 | Hangzhou Bo Zhi Rui Biopharmaceutical Co., Ltd. romanized; Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized |
| 2026/03/03New drug · Class 3.3 | 特立帕肽注射液 · No verified English nameCXSL2600294 | Yi Fan Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/03/03New drug · Class 3.3 | 古塞奇尤单抗注射液 · No verified English nameCXSL2600293 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2026/03/03New drug · Class 1 | HS-20117-2注射液 · No verified English nameCXSL2600290 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2026/03/03New drug · Class 1 | QLS1413片 · No verified English nameCXHL2600264 | Shanghai Qi Lu Pharmaceutical Research Center Co., Ltd. romanized |
| 2026/03/03New drug · Class 1 | QLS1413片 · No verified English nameCXHL2600263 | Shanghai Qi Lu Pharmaceutical Research Center Co., Ltd. romanized |
| 2026/03/03New drug · Class 2.2 | 玛硒洛沙韦干混悬剂 · No verified English nameCXHL2600262 | Zheng Xiang Pharmaceuticals (Nanjing) Group Co., Ltd. romanized |
| 2026/03/03New drug · Class 1 | JYP0061片 · No verified English nameCXHL2600261 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/03/03New drug · Class 1 | JYP0061片 · No verified English nameCXHL2600260 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/03/02Import · Class 3.1 | 尘螨变应原舌下片 (Actair) · No verified English nameJXSL2600061 | STALLERGENES; Nuance Pharma(Beijing)Co. Ltd |
| 2026/03/02Import · Class 3.1 | 尘螨变应原舌下片 (Actair) · No verified English nameJXSL2600060 | STALLERGENES; Nuance Pharma(Beijing)Co. Ltd |
| 2026/03/02Generic · Class 3 | Hydrotalcite SuspensionCYHS2600606 | Anhui Kang Rong Pharma Co., Ltd. romanized |
| 2026/03/02Generic · Class 3 | Methenamine Hippurate TabletsCYHS2600602 | Chengdu Heng Rui Pharmaceutical Co., Ltd. romanized |
| 2026/03/02Generic · Class 3 | Amisulpride Oral SolutionCYHS2600599 | Sichuan Sen Ke Pharmaceutical Co., Ltd. romanized |
| 2026/03/02Generic · Class 3 | 洛度沙胺氨丁三醇滴眼液 · No verified English nameCYHS2600598 | Shijiazhuang No.4 Pharmaceutical Co., Ltd.; Jiangxi Ke Lun Pharma Co., Ltd. romanized |
| 2026/03/02New drug · Class 3.3 | 德谷胰岛素注射液 · No verified English nameCXSS2600034 | Chongqing Chen An Biopharmaceutical Co., Ltd. romanized |
| 2026/03/02New drug · Class 2 | 乙型肝炎病毒、丙型肝炎病毒、人类免疫缺陷病毒(1+2型)核酸检测试剂盒(PCR-荧光法) · No verified English nameCXSS2600033 | Shandong Jian Wei Bio Technology Co., Ltd. romanized |
| 2026/03/02New drug · Class 1 | SKB118注射液 · No verified English nameCXSL2600292 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2026/03/02New drug · Class 1 | 注射用BG-C0979 · No verified English nameCXSL2600291 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2026/03/02New drug · Class 2.2 | 三价流感病毒裂解疫苗(MDCK细胞) · No verified English nameCXSL2600289 | Beijing Ke Xing Bio Zhi Pin Co., Ltd. romanized |
| 2026/03/02New drug · Class 1 | 注射用RC288 · No verified English nameCXSL2600288 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2026/03/02New drug · Class 2.1; 2.2 | 伏欣奇拜单抗注射液 · No verified English nameCXSL2600285 | Changchun Jin Sai Pharma Co., Ltd. romanized |
182 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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