YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 431 drug applications between 5 August 2026 and 11 August 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 75, covering 56 drug names.
2026/08/05 – 2026/08/11
- New acceptances this week
- 431
- Drugs with new generic filings (by drug name, de-duplicated)
- 56
- Accepted this week, now under review
- 214
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
431filings, 75 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 251 |
| Generic | 75 |
| New drug | 73 |
| Import | 22 |
| Unspecified | 5 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 192 |
| TCM | 161 |
| Therapeutic biologic | 73 |
| Prophylactic biologic | 4 |
| 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 | Dapagliflozin Tablets | 4 | 2 | 84 |
| 2 | 替尔泊肽注射液 · No verified English name | 4 | 1 | 22 |
| 3 | Ambroxol Hydrochloride Solution For Inhalation | 3 | 1 | 10 |
| 4 | Brexpiprazole Orally Disintegrating Tablets | 3 | 1 | 10 |
| 5 | 鱼油(3%)橄榄油中/长链脂肪乳/氨基酸(16)/葡萄糖(13%)注射液 · No verified English name | 3 | 1 | 6 |
| 6 | Upadacitinib Sustained-release Tablets | 2 | 2 | 43 |
| 7 | Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ) | 2 | 2 | 17 |
| 8 | Cyclophosphamide for Injection | 2 | 1 | 3 |
| 9 | 盐酸西替利嗪滴剂 · No verified English name | 2 | 1 | 8 |
| 10 | Mirogabalin Besilate Tablets | 2 | 1 | 61 |
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
259 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Liaoning Shang Yao Hao Hu Shi Pharma (Group) Co., Ltd. romanized | 7 | 5 | 0 |
| 2 | Topfond Pharmaceutical Co., Ltd. | 6 | 6 | 0 |
| 3 | Hubei Dong Xin Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Bayer Inc. | 6 | 1 | 0 |
| 5 | Gilead Sciences Inc. | 6 | 1 | 0 |
| 6 | Janssen Research & Development LLC | 5 | 3 | 0 |
| 7 | GlaxoSmithKline Trading Services Limited | 5 | 2 | 0 |
| 8 | Heng Yi Biopharmaceuticals (Jiangsu) Co., Ltd. romanized | 5 | 1 | 0 |
| 9 | Shandong Bu Zhang Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 4 | 4 | 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
116 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/08/11Import · Class 1 | JNJ-79635322 · No verified English nameJXSL2600192 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2026/08/11Import · Class 1 | JNJ-79635322 · No verified English nameJXSL2600191 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2026/08/11Import · Class 2.4 | AZD9833片 · No verified English nameJXHL2600334 | AstraZeneca AB; AstraZeneca Investment (China) Co. Limited |
| 2026/08/11Generic · Class 3 | 盐酸甲氧氯普胺口服溶液 · No verified English nameCYHS2601968 | Anhui Mao Kang Pharma Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized |
| 2026/08/11Generic · Class 3 | Tofacitinib Citrate Oral SolutionCYHS2601966 | Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized |
| 2026/08/11Generic · Class 3 | Irbesartan and Amlodipine TabletsCYHS2601964 | Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized |
| 2026/08/11Generic · Class 3 | Brexpiprazole Orally Disintegrating TabletsCYHS2601963 | Hefei Ying Tai Pharmaceutical Co., Ltd. romanized |
| 2026/08/11Generic · Class 3 | Brexpiprazole Orally Disintegrating TabletsCYHS2601962 | Hefei Ying Tai Pharmaceutical Co., Ltd. romanized |
| 2026/08/11Generic · Class 3 | Brexpiprazole Orally Disintegrating TabletsCYHS2601961 | Hefei Ying Tai Pharmaceutical Co., Ltd. romanized |
| 2026/08/11New drug · Class 1 | KL002注射液 · No verified English nameCXSL2600854 | Kang Lin Bio Technology (Hangzhou) Co., Ltd. romanized |
| 2026/08/11New drug · Class 3.3 | 注射用TKB02 · No verified English nameCXSL2600853 | Anhui Tai En Kang Bio Gong Cheng Co., Ltd. romanized |
| 2026/08/11New drug · Class 1 | 重组柯萨奇病毒B3注射液 · No verified English nameCXSL2600852 | Wuhan Bo Wei De Bio Technology Co., Ltd. romanized |
| 2026/08/11New drug · Class 1 | 盐酸阿氟色替片 · No verified English nameCXHS2600117 | Shanghai Qi Lu Pharmaceutical Research Center Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized |
| 2026/08/11New drug · Class 1 | 盐酸阿氟色替片 · No verified English nameCXHS2600116 | Shanghai Qi Lu Pharmaceutical Research Center Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized |
| 2026/08/10Import · Class 1.4 | PG4 · No verified English nameJXSL2600189 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2026/08/10Import · Class 1 | Venglustat · No verified English nameJXHL2600333 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd |
| 2026/08/10Import · Class 1 | Venglustat · No verified English nameJXHL2600332 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd |
| 2026/08/10Generic · Class 3 | 硫酸特布他林口服溶液 · No verified English nameCYHS2601951 | Shanghai Mei You Pharmaceutical Co., Ltd. romanized |
| 2026/08/10Generic · Class 3 | Landiolol Hydrochloride for InjectionCYHS2601949 | Hainan Ling Kang Pharmaceutical Co., Ltd. romanized |
| 2026/08/10Generic · Class 3 | Probucol TabletsCYHS2601948 | Zhejiang Jiang Bei Pharma Co., Ltd. romanized |
| 2026/08/10Generic · Class 3 | Sivelestat Sodium for InjectionCYHS2601944 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2026/08/10New drug · Class 1.2 | CE-201片 · No verified English nameCXZL2600074 | Yuan Yan Gang (Shanghai) Zhong Yao Technology Co., Ltd. romanized; Yuan Yan Yao Gang Sheng Ming Ke Xue Technology (Beijing) Group Co., Ltd. romanized |
| 2026/08/10New drug · Class 1.2 | CE-201片 · No verified English nameCXZL2600073 | Yuan Yan Gang (Shanghai) Zhong Yao Technology Co., Ltd. romanized; Yuan Yan Yao Gang Sheng Ming Ke Xue Technology (Beijing) Group Co., Ltd. romanized |
| 2026/08/10New drug · Class 1.2 | CE-101 · No verified English nameCXZL2600072 | Yuan Yan Gang (Shanghai) Zhong Yao Technology Co., Ltd. romanized; Yuan Yan Yao Gang Sheng Ming Ke Xue Technology (Beijing) Group Co., Ltd. romanized |
| 2026/08/10New drug · Class 2.1 | 注射用正清风痛宁 · No verified English nameCXZL2600071 | Hunan Zheng Qing Pharmaceutical Group Co., Ltd. romanized |
| 2026/08/10New drug · Class 1 | CM551注射液 · No verified English nameCXSL2600851 | Kang Nuo Ya Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/08/10New drug · Class 3.3 | AK2401注射液 · No verified English nameCXSL2600850 | Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized |
| 2026/08/10New drug · Class 1 | ICP-B381 · No verified English nameCXSL2600849 | Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/08/10New drug · Class 1 | BJ045注射液(皮下注射) · No verified English nameCXSL2600848 | Shanghai Bao Ji Pharma Co., Ltd. romanized |
| 2026/08/10New drug · Class 1 | 90Y-NRT6020注射液 · No verified English nameCXHL2600980 | Chengdu Niu Rui Te Medical Technology Co., Ltd. romanized |
86 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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