YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 448 drug applications between 19 August 2026 and 25 August 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 76, covering 56 drug names.
2026/08/19 – 2026/08/25
- New acceptances this week
- 448
- Drugs with new generic filings (by drug name, de-duplicated)
- 56
- Accepted this week, now under review
- 243
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
448filings, 76 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 238 |
| Generic | 76 |
| New drug | 73 |
| Import | 42 |
| Unspecified | 11 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 230 |
| TCM | 124 |
| Therapeutic biologic | 80 |
| Prophylactic biologic | 12 |
| Biologic | 2 |
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 | Dotinurad Tablets | 4 | 2 | 55 |
| 2 | Brivaracetam Tablets | 3 | 1 | 19 |
| 3 | Linaclotide Capsules | 2 | 2 | 13 |
| 4 | 生理氯化钠溶液 · No verified English name | 2 | 2 | 17 |
| 5 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 6 | Ilaprazole Enteric-coated Tablets | 2 | 2 | 26 |
| 7 | Aspirin Enteric-coated Tablets | 2 | 2 | 10 |
| 8 | Lactulose Oral Solution | 2 | 1 | 34 |
| 9 | Diclofenac Sodium Sustained Release Tablets | 2 | 1 | 10 |
| 10 | Ibuprofen Injection | 2 | 1 | 8 |
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
250 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Gao Miao Pharma Co., Ltd. romanized | 29 | 25 | 0 |
| 2 | Luo Yang Yi Long Pharma Co., Ltd. romanized | 10 | 10 | 0 |
| 3 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 10 | 3 | 0 |
| 4 | AstraZeneca AB | 8 | 5 | 0 |
| 5 | AbbVie Inc. | 8 | 3 | 0 |
| 6 | Novo Nordisk A/S | 7 | 1 | 0 |
| 7 | Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized | 6 | 4 | 0 |
| 8 | Pfizer Inc. | 6 | 3 | 0 |
| 9 | Chengdu Brilliant Pharmaceutical Co., Ltd. | 6 | 3 | 1 |
| 10 | Eli Lilly Italia S.p.A. | 6 | 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
137 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/08/25Generic · Class 3 | 琥珀酸地文拉法辛缓释片 · No verified English nameCYHS2602120 | Zhi En Bio Technology Co., Ltd. romanized |
| 2026/08/25Generic · Class 3 | 琥珀酸地文拉法辛缓释片 · No verified English nameCYHS2602119 | Zhi En Bio Technology Co., Ltd. romanized |
| 2026/08/25Generic · Class 3 | Ferrous Succinate TabletsCYHS2602118 | TC Pharmaceuticals (Jiangsu) Co., Ltd |
| 2026/08/25Generic · Class 3 | Bifonazole SolutionCYHS2602117 | Anhui Pioneer Pharmaceutical Co., Ltd |
| 2026/08/25Generic · Class 3 | Bifonazole SolutionCYHS2602116 | Anhui Pioneer Pharmaceutical Co., Ltd |
| 2026/08/25Generic · Class 3 | Ketoprofen PatchesCYHL2600091 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2026/08/25New drug · Class 1 | 哌普锐基注射液 · No verified English nameCXSS2600132 | Beijing Zhong Yin Technology Co., Ltd. romanized; He Yuan Zhi Zao (Shanghai) Ji Yin Technology Co., Ltd. romanized |
| 2026/08/25New drug · Class 1 | 注射用AN4035 · No verified English nameCXSL2600908 | Hangzhou A Nuo Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/08/25New drug · Class 1 | 人源羊膜3D 间充质基质细胞注射液 · No verified English nameCXSL2600907 | Jiangxi Bei Zheng Gan Xi Bao Bio Technology Co., Ltd. romanized |
| 2026/08/25New drug · Class 1 | 注射用SKB500 · No verified English nameCXSL2600906 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2026/08/25New drug · Class 1 | SKB118注射液 · No verified English nameCXSL2600905 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2026/08/25New drug · Class 1 | ST-1703片 · No verified English nameCXHL2601044 | Beijing Sai Te Ming Qiang Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/08/25New drug · Class 2.2 | 秋水仙碱缓释胶囊 · No verified English nameCXHL2601043 | Zhongguo Ren Min Jie Fang Jun Jun Shi Ke College Jun Shi Yi Xue Research Institute romanized |
| 2026/08/25New drug · Class 2.2 | 秋水仙碱缓释胶囊 · No verified English nameCXHL2601042 | Zhongguo Ren Min Jie Fang Jun Jun Shi Ke College Jun Shi Yi Xue Research Institute romanized |
| 2026/08/25New drug · Class 2.2 | 秋水仙碱缓释胶囊 · No verified English nameCXHL2601041 | Zhongguo Ren Min Jie Fang Jun Jun Shi Ke College Jun Shi Yi Xue Research Institute romanized |
| 2026/08/24Import · Class 1 | 依赛弗酶α注射液(皮下注射) · No verified English nameJXSS2600078 | Alexion Europe SAS; Alexion Pharma International Operations Limited Alexion Athlone Manufacturing Facility (AAMF); AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/08/24Import · Class 1 | 依赛弗酶α注射液(皮下注射) · No verified English nameJXSS2600077 | Alexion Europe SAS; Alexion Pharma International Operations Limited Alexion Athlone Manufacturing Facility (AAMF); AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/08/24Import · Class 1 | 依赛弗酶α注射液(皮下注射) · No verified English nameJXSS2600076 | Alexion Europe SAS; Alexion Pharma International Operations Limited Alexion Athlone Manufacturing Facility (AAMF); AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/08/24Import · Class 3.1 | 13价肺炎球菌多糖结合疫苗 · No verified English nameJXSL2600227 | Pfizer Europe MA EEIG; Pfizer Investment CO. Ltd. |
| 2026/08/24Import · Class 3.1 | 20价肺炎球菌多糖结合疫苗 · No verified English nameJXSL2600226 | Pfizer Europe MA EEIG; Pfizer Investment CO. Ltd. |
| 2026/08/24Import · Class 1 | ARVN901 · No verified English nameJXSL2600225 | Arctic Vision (Hong Kong) Limited; Arctic Vision (Shanghai) Biotechnology Co. Ltd. |
| 2026/08/24Import · Class 1 | DS-3939a · No verified English nameJXSL2600224 | Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2026/08/24Import · Class 1 | AZD8205 · No verified English nameJXSL2600223 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/08/24Import · Class 1 | Telisotuzumab Adizutecan 注射用粉末 · No verified English nameJXSL2600222 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd |
| 2026/08/24Import · Class 1 | AZD9574 · No verified English nameJXHL2600362 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/08/24Import · Class 1 | AZD9574 · No verified English nameJXHL2600361 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/08/24Import · Class 1 | CBL-514注射液 · No verified English nameJXHL2600360 | Caliway Biopharmaceuticals Co. Ltd.; Hangzhou Tigermed Consulting Co. Ltd. |
| 2026/08/24Generic · Class 3 | Ibuprofen InjectionCYHS2602108 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized |
| 2026/08/24Generic · Class 3 | Ibuprofen InjectionCYHS2602107 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized |
| 2026/08/24Generic · Class 3 | 奥美拉唑碳酸氢钠干混悬剂(Ⅰ) · No verified English nameCYHS2602102 | Changzhou Rui Ming Pharma Co., Ltd. romanized |
107 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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