YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 449 drug applications between 26 June 2026 and 2 July 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 75, covering 52 drug names.
2026/06/26 – 2026/07/02
- New acceptances this week
- 449
- Drugs with new generic filings (by drug name, de-duplicated)
- 52
- Accepted this week, now under review
- 131
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
449filings, 75 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 277 |
| Generic | 75 |
| New drug | 55 |
| Import | 18 |
| Unspecified | 16 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 232 |
| TCM | 167 |
| Therapeutic biologic | 43 |
| Biologic | 7 |
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
52 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 司美格鲁肽注射液 · No verified English name | 5 | 1 | 92 |
| 2 | Nafamostat Mesilate for Injection | 4 | 2 | 38 |
| 3 | Adapalene And Benzoyl Peroxide Gel | 4 | 2 | 30 |
| 4 | Dopamine Hydrochloride Injection | 3 | 1 | 3 |
| 5 | Landiolol Hydrochloride for Injection | 2 | 2 | 19 |
| 6 | Lactulose Oral Solution | 2 | 1 | 34 |
| 7 | 依折麦布阿托伐他汀钙片(Ⅰ)、(Ⅱ) · No verified English name | 2 | 1 | 2 |
| 8 | Eplerenone Tablets | 2 | 1 | 4 |
| 9 | Dotinurad Tablets | 2 | 1 | 55 |
| 10 | 环索奈德吸入气雾剂 · No verified English name | 2 | 1 | 0 |
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
289 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized | 16 | 7 | 0 |
| 2 | Yan Tai Xin Ke Si Da Pharmaceuticals Technology Co., Ltd. romanized | 7 | 7 | 0 |
| 3 | Xizang Gan Lu Zang Yao Co., Ltd. romanized | 7 | 5 | 0 |
| 4 | Lan Yun Zhi He Bio Technology Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 6 | 5 | 0 |
| 6 | Bristol-Myers Squibb Company | 5 | 2 | 0 |
| 7 | Jiangsu Fu Bang Pharma Co., Ltd. romanized | 5 | 2 | 5 |
| 8 | Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized | 5 | 1 | 5 |
| 9 | Gansu He Xi Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized | 4 | 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
108 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/07/02Import · Class 1 | Rinzimetostat (ORIC-944) · No verified English nameJXHL2600240 | ORIC Pharmaceuticals Inc.; ICON Clinical Research (Beijing No. 2) Co. Ltd. |
| 2026/07/02Generic · Class 3 | 司美格鲁肽注射液 · No verified English nameCYHS2601574 | Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized; Shenzhen Han Yu Pharma Co., Ltd. romanized |
| 2026/07/02Generic · Class 3 | 司美格鲁肽注射液 · No verified English nameCYHS2601573 | Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized; Shenzhen Han Yu Pharma Co., Ltd. romanized |
| 2026/07/02Generic · Class 3 | 司美格鲁肽注射液 · No verified English nameCYHS2601572 | Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized; Shenzhen Han Yu Pharma Co., Ltd. romanized |
| 2026/07/02Generic · Class 3 | 司美格鲁肽注射液 · No verified English nameCYHS2601571 | Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized; Shenzhen Han Yu Pharma Co., Ltd. romanized |
| 2026/07/02Generic · Class 3 | 司美格鲁肽注射液 · No verified English nameCYHS2601570 | Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized; Shenzhen Han Yu Pharma Co., Ltd. romanized |
| 2026/07/02Generic · Class 3 | 枸橼酸西地那非口溶膜 · No verified English nameCYHS2601564 | 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 |
| 2026/07/02New drug · Class 3.1 | 桃红四物汤颗粒 · No verified English nameCXZS2600035 | Zhu Zhou Qian Jin Pharma Co., Ltd. romanized |
| 2026/07/02New drug · Class 1.1 | 柴芍肠宁颗粒 · No verified English nameCXZL2600058 | Yu Sen (Fo Shan) Xin Yao Research and Development Co., Ltd. romanized |
| 2026/07/02New drug · Class 1 | HXN6005注射液 · No verified English nameCXSL2600691 | Hua Shen Zhi Yao Bio Technology (Suzhou) Co., Ltd. romanized |
| 2026/07/02New drug · Class 1 | 乐德奇拜单抗注射液 · No verified English nameCXSL2600690 | Xian Sheng Pharma Co., Ltd. romanized |
| 2026/07/02New drug · Class 1 | 乐德奇拜单抗注射液 · No verified English nameCXSL2600689 | Xian Sheng Pharma Co., Ltd. romanized |
| 2026/07/02New drug · Class 1 | EA5注射液皮下制剂 · No verified English nameCXSL2600688 | Shanghai Lan Yi Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/07/02New drug · Class 1 | 注射用JY1001 · No verified English nameCXHL2600792 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized |
| 2026/07/02New drug · Class 2.2; 2.4 | F2008吸入粉雾剂 · No verified English nameCXHL2600791 | Suzhou Yi He Pharmaceuticals Co., Ltd. romanized |
| 2026/07/02New drug · Class 1 | QLS1510片 · No verified English nameCXHL2600790 | Shanghai Qi Lu Pharmaceutical Research Center Co., Ltd. romanized |
| 2026/07/02New drug · Class 1 | QLS1510片 · No verified English nameCXHL2600789 | Shanghai Qi Lu Pharmaceutical Research Center Co., Ltd. romanized |
| 2026/07/02New drug · Class 1 | MDR-001片 · No verified English nameCXHL2600788 | Hangzhou De Rui Zhi Yao Technology Co., Ltd. romanized |
| 2026/07/02New drug · Class 1 | MDR-001片 · No verified English nameCXHL2600787 | Hangzhou De Rui Zhi Yao Technology Co., Ltd. romanized |
| 2026/07/02New drug · Class 2.2; 2.4 | SQ-23082滴眼液 · No verified English nameCXHL2600786 | Shenyang Xing Qi Yan Yao Co., Ltd. romanized |
| 2026/07/02New drug · Class 2.2; 2.4 | SQ-23082滴眼液 · No verified English nameCXHL2600785 | Shenyang Xing Qi Yan Yao Co., Ltd. romanized |
| 2026/07/02New drug · Class 2.2; 2.4 | SQ-23082滴眼液 · No verified English nameCXHL2600784 | Shenyang Xing Qi Yan Yao Co., Ltd. romanized |
| 2026/07/01Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSS2600056 | MSD International Business GmbH; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd |
| 2026/07/01Import · Class 2.4 | 那米司特片 · No verified English nameJXHL2600239 | Boehringer lngelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2026/07/01Import · Class 2.4 | 那米司特片 · No verified English nameJXHL2600238 | Boehringer lngelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2026/07/01Generic · Class 3 | Bilastine Oral SolutionCYHS2601558 | Zhuhai Bei Shan Bio Technology Co., Ltd. romanized; Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized |
| 2026/07/01Generic · Class 3 | Landiolol Hydrochloride for InjectionCYHS2601557 | Kang Pu Pharma Co., Ltd. romanized |
| 2026/07/01Generic · Class 3 | Peramivir InjectionCYHS2601554 | CISEN PHARMACEUTICAL CO., LTD. |
| 2026/07/01Generic · Class 3 | Isoprenaline Hydrochloride InjectionCYHS2601553 | Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2026/07/01Generic · Class 3 | Isoprenaline Hydrochloride InjectionCYHS2601552 | Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
78 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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