YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 458 drug applications between 18 August 2026 and 24 August 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 77, covering 54 drug names.
2026/08/18 – 2026/08/24
- New acceptances this week
- 458
- Drugs with new generic filings (by drug name, de-duplicated)
- 54
- Accepted this week, now under review
- 240
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
458filings, 77 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 242 |
| Generic | 77 |
| New drug | 68 |
| Import | 49 |
| Unspecified | 14 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 230 |
| TCM | 136 |
| Therapeutic biologic | 78 |
| 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
54 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Febuxostat Tablets | 4 | 2 | 12 |
| 2 | Glucosamine Sulfate Capsules | 3 | 3 | 51 |
| 3 | Brivaracetam Tablets | 3 | 1 | 19 |
| 4 | Pirfenidone Tablets | 2 | 2 | 5 |
| 5 | 氧(液态) · No verified English name | 2 | 2 | 13 |
| 6 | Landiolol Hydrochloride for Injection | 2 | 2 | 19 |
| 7 | 生理氯化钠溶液 · No verified English name | 2 | 2 | 17 |
| 8 | Iguratimod Tablets | 2 | 2 | 23 |
| 9 | Ilaprazole Enteric-coated Tablets | 2 | 2 | 26 |
| 10 | Aspirin Enteric-coated Tablets | 2 | 2 | 10 |
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
261 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Gao Miao Pharma Co., Ltd. romanized | 23 | 19 | 0 |
| 2 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 10 | 3 | 0 |
| 3 | Eli Lilly and Company | 8 | 2 | 0 |
| 4 | Jilin Dao Jun Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 5 | AstraZeneca AB | 7 | 4 | 0 |
| 6 | Pfizer Inc. | 7 | 4 | 0 |
| 7 | Novo Nordisk A/S | 7 | 1 | 0 |
| 8 | Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized | 6 | 4 | 0 |
| 9 | AbbVie Inc. | 6 | 2 | 0 |
| 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 |
|---|---|---|
| 2026/08/24Import · 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 |
| 2026/08/24Generic · Class 3 | Phenylephrine Hydrochloride InjectionCYHS2602101 | Jiangsu Fu Bang Pharma Co., Ltd. romanized |
| 2026/08/24Generic · Class 3 | Phenylephrine Hydrochloride InjectionCYHS2602100 | Jiangsu Fu Bang Pharma Co., Ltd. romanized |
| 2026/08/24Generic · Class 3 | Folic Acid TabletsCYHS2602096 | Beijing Heng Sheng Pharma Co., Ltd. romanized |
| 2026/08/24Generic · Class 3 | Raltitrexed for InjectionCYHS2602095 | Sichuan Shuang Tong Medical Technology Co., Ltd. romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2026/08/24Generic · Class 3 | Methocarbamol TabletsCYHS2602094 | Le Sheng Pharma Shijiazhuang Co., Ltd. romanized |
| 2026/08/24Generic · Class 3 | Roxatidine Acetate Hydrochloride For InjectionCYHS2602093 | Liao Cheng Gao Xin Bio Technology Co., Ltd. romanized; Jin Cheng Hai Si Pharmaceutical Co., Ltd. romanized |
| 2026/08/24Generic · Class 3 | Dapagliflozin and Saxagliptin TabletsCYHL2600089 | Hefei He Yuan Pharma Co., Ltd. romanized |
| 2026/08/24New drug · Class 1.1 | 芪珀生脉颗粒 · No verified English nameCXZL2600080 | Beijing Chun Feng Pharma Co., Ltd. romanized |
| 2026/08/24New drug · Class 1 | 注射用ZL-1310 · No verified English nameCXSL2600904 | Zai Ding Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/08/24New drug · Class 1 | GA002注射液 · No verified English nameCXSL2600903 | Jian Da Jiu Zhou (Beijing) Bio Technology Co., Ltd. romanized |
| 2026/08/24New drug · Class 2.2 | 奥妥珠单抗β注射液 · No verified English nameCXSL2600902 | Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized |
| 2026/08/24New drug · Class 1 | 重组NV-A01腺病毒注射液 · No verified English nameCXSL2600901 | Nanjing Nuo Wei Bio Technology Co., Ltd. romanized |
| 2026/08/24New drug · Class 2.2 | 奥妥珠单抗β注射液 · No verified English nameCXSL2600900 | Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized |
| 2026/08/24New 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 nameCXSL2600899 | Suzhou Ruo Yi Bio Technology Co., Ltd. romanized |
| 2026/08/24New drug · Class 1 | RC148注射液 · No verified English nameCXSL2600898 | Rong Chang Biopharmaceutical (Yan Tai) 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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