YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 499 drug applications between 21 July 2026 and 27 July 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 62, covering 48 drug names.
2026/07/21 – 2026/07/27
- New acceptances this week
- 499
- Drugs with new generic filings (by drug name, de-duplicated)
- 48
- Accepted this week, now under review
- 160
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
499filings, 62 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 309 |
| New drug | 79 |
| Generic | 62 |
| Import | 29 |
| Unspecified | 17 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 243 |
| TCM | 165 |
| Therapeutic biologic | 77 |
| Biologic | 8 |
| Prophylactic biologic | 6 |
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
48 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 | Adapalene Gel | 3 | 3 | 30 |
| 3 | Oseltamivir Phosphate Capsules | 3 | 1 | 39 |
| 4 | Ambroxol Hydrochloride Solution For Inhalation | 2 | 2 | 10 |
| 5 | Dotinurad Tablets | 2 | 1 | 55 |
| 6 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 7 | Sacubitril Valsartan Sodium Tablets | 2 | 1 | 70 |
| 8 | Sodium Hyaluronate Eye Drops | 2 | 1 | 30 |
| 9 | Ambroxol Hydrochloride Oral Solution | 2 | 1 | 46 |
| 10 | Roxadustat Capsules | 2 | 1 | 17 |
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
295 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Novo Nordisk A/S | 21 | 6 | 0 |
| 2 | Jiangxi Jiu Lian Shan Pharma Co., Ltd. romanized | 10 | 9 | 0 |
| 3 | Merck Sharp & Dohme LLC | 8 | 4 | 0 |
| 4 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 7 | 2 | 0 |
| 5 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 6 | 3 | 0 |
| 6 | Changchun Jin Sai Pharma Co., Ltd. romanized | 6 | 3 | 0 |
| 7 | Shaanxi Dong Tai Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Li Shi Zhen Pharmaceuticals Group Co., Ltd. romanized | 5 | 4 | 0 |
| 9 | Pfizer Inc. | 5 | 2 | 0 |
| 10 | Bao Tou Zhong Yao Co., Ltd. romanized | 5 | 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
115 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/07/27Import · Class 1 | PF-08653944注射液 · No verified English nameJXHL2600291 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/07/27Import · Class 1 | PF-08653944注射液 · No verified English nameJXHL2600290 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/07/27Import · Class 1 | PF-08653944注射液 · No verified English nameJXHL2600289 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/07/27Import · Class 1 | PF-08653944注射液 · No verified English nameJXHL2600288 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/07/27Import · Class 1 | RO7568282胶囊 · No verified English nameJXHL2600287 | F. Hoffmann-La Roche Ltd; Roche R&D Center (China) Ltd. |
| 2026/07/27Import · Class 1 | RO7568282胶囊 · No verified English nameJXHL2600286 | F. Hoffmann-La Roche Ltd; Roche R&D Center (China) Ltd. |
| 2026/07/27Generic · Class 3 | Sodium Lactate Ringer's Irrigation SolutionCYHS2601790 | Hunan Kang Yuan Pharmaceutical Co., Ltd. romanized |
| 2026/07/27Generic · Class 3 | Ambroxol Hydrochloride Solution For InhalationCYHS2601788 | Nanjing Hua Gai Pharmaceutical Co., Ltd. romanized |
| 2026/07/27Generic · Class 3 | Bifonazole SolutionCYHS2601784 | Suzhou Gao Mai Pharma Co., Ltd. romanized; Tang Shan Hong Xing Pharma Co., Ltd. romanized |
| 2026/07/27New drug · Class 1.1 | TDX105颗粒 · No verified English nameCXZL2600066 | Tian Shi Li Pharmaceuticals Group Co., Ltd. romanized |
| 2026/07/27New drug · Class 2.4 | 注射用重组A型肉毒毒素(Sf9细胞,150 kD天然氨基酸序列) · No verified English nameCXSL2600779 | Suzhou Ruo Yi Bio Technology Co., Ltd. romanized |
| 2026/07/27New drug · Class 1 | Cizutamig注射液(皮下注射) · No verified English nameCXSL2600778 | Shanghai Tan Di Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/07/27New drug · Class 1 | TGI-10注射液 · No verified English nameCXSL2600777 | Hefei Tian Gang Mian Yi Drug Co., Ltd. romanized |
| 2026/07/27New drug · Class 1 | NouvSight001 · No verified English nameCXSL2600776 | Rui Jian Yi Lian Pharmaceuticals Technology (Chengdu) Co., Ltd. romanized; Wuhan Rui Jian Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/07/27New drug · Class 1 | GenSci155注射液 · No verified English nameCXSL2600775 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2026/07/27New drug · Class 1 | GenSci155注射液 · No verified English nameCXSL2600774 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2026/07/27New drug · Class 1 | LDR1259注射液 · No verified English nameCXHL2600918 | Chengdu Xian Yan Bio Technology Co., Ltd. romanized |
| 2026/07/27New drug · Class 1 | IMP1734片 · No verified English nameCXHL2600917 | Shanghai Ying Pai Pharma Co., Ltd. romanized |
| 2026/07/27New drug · Class 1 | IMP1734片 · No verified English nameCXHL2600916 | Shanghai Ying Pai Pharma Co., Ltd. romanized |
| 2026/07/27New drug · Class 1 | QX-6胶囊 · No verified English nameCXHL2600915 | Jiangxi Pu Zheng Pharmaceutical Co., Ltd. romanized; Zhongguo Yi Xue Ke College Yao Yong Zhi Wu Research Institute romanized |
| 2026/07/27New drug · Class 1 | QX-6胶囊 · No verified English nameCXHL2600914 | Jiangxi Pu Zheng Pharmaceutical Co., Ltd. romanized; Zhongguo Yi Xue Ke College Yao Yong Zhi Wu Research Institute romanized |
| 2026/07/27New drug · Class 1 | 737NL01注射液 · No verified English nameCXHL2600913 | Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2026/07/27New drug · Class 1 | 737NL01注射液 · No verified English nameCXHL2600912 | Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2026/07/27New drug · Class 1 | HSK56630片 · No verified English nameCXHL2600911 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized |
| 2026/07/27New drug · Class 1 | HSK56630片 · No verified English nameCXHL2600910 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized |
| 2026/07/27New drug · Class 2.4 | 复方RY2乳膏 · No verified English nameCXHL2600909 | Nanjing Rui Ying Run Ze Biopharmaceuticals Technology Co., Ltd. romanized; Zhongguo Yao Ke University romanized; Shandong Run Ze Zi Hua Pharma Co., Ltd. romanized |
| 2026/07/27New drug · Class 2.4 | 复方RY2乳膏 · No verified English nameCXHL2600908 | Nanjing Rui Ying Run Ze Biopharmaceuticals Technology Co., Ltd. romanized; Zhongguo Yao Ke University romanized; Shandong Run Ze Zi Hua Pharma Co., Ltd. romanized |
| 2026/07/27New drug · Class 2.4 | 复方RY2乳膏 · No verified English nameCXHL2600907 | Nanjing Rui Ying Run Ze Biopharmaceuticals Technology Co., Ltd. romanized; Zhongguo Yao Ke University romanized; Shandong Run Ze Zi Hua Pharma Co., Ltd. romanized |
| 2026/07/24Import · Class 2.2 | MK-3475A注射液 · No verified English nameJXSL2600177 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2026/07/24Import · Class 2.2 | MK-3475A注射液 · No verified English nameJXSL2600176 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
85 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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