YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 482 drug applications between 4 August 2026 and 10 August 2026 (data as of 14 November 2026 06:00). Of these, generic applications numbered 76, covering 55 drug names.
2026/08/04 – 2026/08/10
- New acceptances this week
- 482
- Drugs with new generic filings (by drug name, de-duplicated)
- 55
- Accepted this week, now under review
- 237
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
482filings, 76 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 279 |
| New drug | 88 |
| Generic | 76 |
| Import | 29 |
| Import re-registration | 6 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 210 |
| TCM | 193 |
| Therapeutic biologic | 76 |
| Prophylactic biologic | 3 |
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
55 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 | Loxoprofen Sodium Patches | 3 | 2 | 30 |
| 4 | Ambroxol Hydrochloride Solution For Inhalation | 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 | 40 |
| 7 | Edaravone and Dexborneol Concentrated Solution for Injection | 2 | 2 | 34 |
| 8 | Sivelestat Sodium for Injection | 2 | 2 | 5 |
| 9 | Cyclophosphamide for Injection | 2 | 1 | 3 |
| 10 | Nafamostat Mesilate for Injection | 2 | 1 | 38 |
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
276 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Beijing Bao Shu Tang Technology Pharma Co., Ltd. romanized | 17 | 16 | 0 |
| 2 | Liaoning Shang Yao Hao Hu Shi Pharma (Group) Co., Ltd. romanized | 7 | 5 | 0 |
| 3 | Eli Lilly and Company | 7 | 1 | 0 |
| 4 | Topfond Pharmaceutical Co., Ltd. | 6 | 6 | 0 |
| 5 | Bayer Inc. | 6 | 1 | 0 |
| 6 | Gilead Sciences Inc. | 6 | 1 | 0 |
| 7 | Li Zhu Group Li Min Pharmaceutical Factory romanized | 6 | 1 | 0 |
| 8 | GlaxoSmithKline Trading Services Limited | 5 | 2 | 0 |
| 9 | Heng Yi Biopharmaceuticals (Jiangsu) Co., Ltd. romanized | 5 | 1 | 0 |
| 10 | Lian Yun Gang Run Zhong Pharmaceutical Co., Ltd. romanized | 5 | 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
138 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2026/08/10New drug · Class 1 | HRS-5346 片 · No verified English nameCXHL2600979 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/08/10New drug · Class 1 | HRS-2189片 · No verified English nameCXHL2600978 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/08/10New drug · Class 1 | HRS-2189片 · No verified English nameCXHL2600977 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/08/07Import · Class 3.1 | 尼塞韦单抗注射液 · No verified English nameJXSS2600072 | Sanofi Winthrop Industrie; Patheon Manufacturing Services LLC; Sanofi (China) Investment Co. Ltd. |
| 2026/08/07Import · Class 3.1 | 尼塞韦单抗注射液 · No verified English nameJXSS2600071 | Sanofi Winthrop Industrie; Patheon Manufacturing Services LLC; Sanofi (China) Investment Co. Ltd. |
| 2026/08/07Import · Class 1 | Edecesertib 片 · No verified English nameJXHL2600331 | Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd. |
| 2026/08/07Import · Class 1 | Edecesertib 片 · No verified English nameJXHL2600330 | Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd. |
| 2026/08/07Import · Class 1 | Edecesertib 片 · No verified English nameJXHL2600329 | Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd. |
| 2026/08/07Generic · Class 3 | Ferrous Succinate TabletsCYHS2601935 | Anhui Zheng Yao Pharmaceuticals Technology Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2026/08/07Generic · Class 3 | Acetaminophen InjectionCYHS2601934 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. |
| 2026/08/07Generic · Class 3 | Gatifloxacin Eye DropsCYHS2601932 | Run Er Yan Ke Drug (Guangzhou) Co., Ltd. romanized |
| 2026/08/07Generic · Class 3 | Ropinirole Hydrochloride TabletsCYHS2601930 | Da Tong Pharmaceutical (Zhongguo) Co., Ltd. romanized |
| 2026/08/07New drug · Class 3.1 | 当归六黄汤颗粒 · No verified English nameCXZS2600045 | Shen Wei Pharma Group Co., Ltd. romanized |
| 2026/08/07New drug · Class 3.1 | 厚朴温中汤颗粒 · No verified English nameCXZS2600044 | Shen Wei Pharma Group Co., Ltd. romanized |
108 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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