YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 423 drug applications between 13 July 2026 and 19 July 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 66, covering 48 drug names.
2026/07/13 – 2026/07/19
- New acceptances this week
- 423
- Drugs with new generic filings (by drug name, de-duplicated)
- 48
- Accepted this week, now under review
- 138
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
423filings, 66 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 252 |
| Generic | 66 |
| New drug | 60 |
| Import | 26 |
| Unspecified | 14 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 213 |
| TCM | 131 |
| Therapeutic biologic | 68 |
| Prophylactic biologic | 7 |
| Biologic | 4 |
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 | Ethyl Iosapentate Capsules | 3 | 2 | 27 |
| 2 | Dotinurad Tablets | 3 | 1 | 55 |
| 3 | Brivaracetam Tablets | 3 | 1 | 19 |
| 4 | 瑞维那新吸入溶液 · No verified English name | 2 | 2 | 53 |
| 5 | Buprenorphine Transdermal Patches | 2 | 1 | 6 |
| 6 | Gatifloxacin Eye Drops | 2 | 1 | 3 |
| 7 | Oxaliplatin Injection | 2 | 1 | 4 |
| 8 | Baricitinib Tablets | 2 | 1 | 32 |
| 9 | Cefuroxime Sodium for Injection | 2 | 1 | 8 |
| 10 | 甲苯磺酸卢美哌隆胶囊 · No verified English name | 2 | 1 | 2 |
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
263 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Pfizer Inc. | 10 | 2 | 0 |
| 2 | An Kang Zheng Da Pharmaceutical Co., Ltd. romanized | 6 | 5 | 0 |
| 3 | Les Laboratoires Servier | 6 | 4 | 0 |
| 4 | Amgen Inc. | 6 | 1 | 0 |
| 5 | Hangzhou Bai Xin Biopharmaceuticals Technology Co., Ltd. romanized | 6 | 1 | 0 |
| 6 | Shanxi Huang He Zhong Yao Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Qinghai Di Ma Er Zang Yao Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Novo Nordisk A/S | 5 | 2 | 0 |
| 9 | Beijing Xian Sheng Xiang Rui Bio Zhi Pin Co., Ltd. romanized | 5 | 2 | 0 |
| 10 | Nanjing Tong Ren Tang Pharma 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
114 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/07/18Generic · Class 3 | 枸橼酸铁片 · No verified English nameCYHS2601721 | Jiangsu Ziyond Pharmaceutical Co., Ltd. |
| 2026/07/18New drug · Class 1 | 注射用依康坦博妥塔单抗 · No verified English nameCXSS2600109 | Shanghai Yi Lian Biopharmaceuticals Co., Ltd. romanized; Name not romanized |
| 2026/07/18New drug · Class 2.4 | 瑞维鲁胺片 · No verified English nameCXHL2600871 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/07/18New drug · Class 1 | 注射用JZ1108i聚合物胶束 · No verified English nameCXHL2600870 | Name not romanized |
| 2026/07/17Import · Class 1 | Afimkibart注射液 · No verified English nameJXSL2600171 | F. Hoffmann-La Roche Ltd. |
| 2026/07/17Import · Class 1 | Afimkibart注射液 · No verified English nameJXSL2600170 | F. Hoffmann-La Roche Ltd. |
| 2026/07/17Import · Class 2.4 | 塞普替尼胶囊 · No verified English nameJXHS2600077 | Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; Lilly Suzhou Pharmaceutical Co. Ltd |
| 2026/07/17Import · Class 2.4 | 塞普替尼胶囊 · No verified English nameJXHS2600076 | Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; Lilly Suzhou Pharmaceutical Co. Ltd |
| 2026/07/17Generic · Class 3 | Bilastine Oral SolutionCYHS2601719 | Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2026/07/17Generic · Class 3 | Dexmedetomidine Hydrochloride InjectionCYHS2601718 | Kang Nuo Biopharmaceutical Co., Ltd. romanized |
| 2026/07/17Generic · Class 3 | Dihydroxyaluminum Aminoacetate, Heavy Magnesium Carbonate and Aspirin Tablets(Ⅱ)CYHS2601714 | ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
| 2026/07/17Generic · Class 3 | Nafamostat Mesilate for InjectionCYHS2601711 | Fujian Da Pu Biopharmaceuticals Co., Ltd. romanized; Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized |
| 2026/07/17Generic · Class 3 | Gatifloxacin Eye DropsCYHS2601710 | Zhuhai Qian Lie Pharma Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD |
| 2026/07/17Generic · Class 3 | Gatifloxacin Eye DropsCYHS2601709 | Zhuhai Qian Lie Pharma Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD |
| 2026/07/17New drug · Class 2.3 | 季德胜蛇药片 · No verified English nameCXZL2600062 | Jing Hua Pharmaceutical Group Co., Ltd. romanized |
| 2026/07/17New drug · Class 1 | 注射用HS-20093 · No verified English nameCXSL2600745 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2026/07/17New drug · Class 1 | 注射用LM-2417 · No verified English nameCXSL2600744 | Li Xin Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/07/17New drug · Class 1 | HX15001注射液 · No verified English nameCXSL2600743 | Hua Shen Zhi Yao Bio Technology (Suzhou) Co., Ltd. romanized |
| 2026/07/17New drug · Class 1 | SCTB41注射液 · No verified English nameCXSL2600742 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2026/07/17New drug · Class 3.3 | 达雷妥尤单抗注射液(皮下注射) · No verified English nameCXSL2600741 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2026/07/17New drug · Class 2.4 | 妥拉美替尼胶囊 · No verified English nameCXHL2600869 | Shanghai Ke Zhou Drug Co., Ltd. romanized |
| 2026/07/17New drug · Class 1 | RCZY690片 · No verified English nameCXHL2600868 | Yan Tai Rong Chang Pharmaceutical Co., Ltd. romanized |
| 2026/07/17New drug · Class 1 | RCZY690片 · No verified English nameCXHL2600867 | Yan Tai Rong Chang Pharmaceutical Co., Ltd. romanized |
| 2026/07/17New drug · Class 1 | DIP-1018胶囊 · No verified English nameCXHL2600866 | Zhejiang University romanized; Zhejiang University Jin Hua Research Institute romanized; Name not romanized; Ao Rui Te Pharma Co., Ltd. romanized |
| 2026/07/17New drug · Class 1 | DIP-1018胶囊 · No verified English nameCXHL2600865 | Zhejiang University romanized; Zhejiang University Jin Hua Research Institute romanized; Name not romanized; Ao Rui Te Pharma Co., Ltd. romanized |
| 2026/07/16Import · Class 1 | zenagamtide注射液 · No verified English nameJXSL2600169 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/07/16Import · Class 1 | zenagamtide注射液 · No verified English nameJXSL2600168 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/07/16Import · Class 1 | zenagamtide注射液 · No verified English nameJXSL2600167 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/07/16Import · Class 1 | zenagamtide注射液 · No verified English nameJXSL2600166 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/07/16Generic · Class 3 | 苯磺酸氨氯地平口服溶液 · No verified English nameCYHS2601703 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized |
84 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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