YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 338 drug applications between 16 August 2025 and 22 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 86, covering 63 drug names.
2025/08/16 – 2025/08/22
- New acceptances this week
- 338
- Drugs with new generic filings (by drug name, de-duplicated)
- 63
- Accepted this week, now under review
- 102
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
338filings, 86 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 161 |
| Generic | 86 |
| New drug | 63 |
| Import | 15 |
| Unspecified | 7 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 214 |
| TCM | 62 |
| Therapeutic biologic | 54 |
| Biologic | 5 |
| 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
63 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 卡格列净二甲双胍缓释片 · No verified English name | 4 | 1 | 5 |
| 2 | Fexofenadine Hydrochloride Tablets | 4 | 1 | 10 |
| 3 | Bifonazole Solution | 3 | 3 | 15 |
| 4 | Vonoprazan Fumarate Tablets | 3 | 2 | 60 |
| 5 | Mirogabalin Besilate Tablets | 3 | 2 | 61 |
| 6 | Letermovir Tablets | 2 | 2 | 7 |
| 7 | 瑞维那新吸入溶液 · No verified English name | 2 | 2 | 53 |
| 8 | 左乙拉西坦微片 · No verified English name | 2 | 1 | 2 |
| 9 | 布比卡因脂质体注射液 · No verified English name | 2 | 1 | 7 |
| 10 | 帕拉米韦氯化钠注射液 · No verified English name | 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
224 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Eli Lilly and Company | 8 | 2 | 0 |
| 2 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 6 | 2 | 0 |
| 3 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 5 | 5 | 0 |
| 4 | AstraZeneca AB | 4 | 3 | 0 |
| 5 | Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc. | 4 | 1 | 0 |
| 6 | Le Pu Pharma Co., Ltd. romanized | 4 | 1 | 4 |
| 7 | Sichuan Pharmaceutical Formulations Co., Ltd. romanized | 4 | 1 | 0 |
| 8 | Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized | 4 | 1 | 0 |
| 9 | Zhi En Bio Technology Co., Ltd. romanized | 4 | 1 | 4 |
| 10 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 4 | 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
110 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/08/22Import · Class 2.4 | 尼拉帕利阿比特龙片 · No verified English nameJXHS2500089 | Janssen-Cilag International NV; Patheon France; Xian Janssen Pharmaceutical Ltd. |
| 2025/08/22Import · Class 2.4 | 尼拉帕利阿比特龙片 · No verified English nameJXHS2500088 | Janssen-Cilag International NV; Patheon France; Xian Janssen Pharmaceutical Ltd. |
| 2025/08/22Import · Class 1 | LOXO-435片 · No verified English nameJXHL2500225 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/08/22Import · Class 1 | LOXO-435片 · No verified English nameJXHL2500224 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/08/22Generic · Class 3 | Fexofenadine Hydrochloride Oral SuspensionCYHS2503082 | Hangzhou Hong You Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shuo De Pharma Co., Ltd. romanized |
| 2025/08/22Generic · Class 3 | 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2503080 | Zhejiang Hang Kang Pharma Co., Ltd. romanized |
| 2025/08/22Generic · Class 3 | 注射用哌拉西林钠/氯化钠注射液 · No verified English nameCYHS2503074 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2025/08/22Generic · Class 3 | 注射用哌拉西林钠/氯化钠注射液 · No verified English nameCYHS2503073 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2025/08/22New drug · Class 3.1 | 一贯煎颗粒 · No verified English nameCXZS2500036 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2025/08/22New drug · Class 1 | GA001注射液 · No verified English nameCXSL2500729 | Jian Da Jiu Zhou (Beijing) Bio Technology Co., Ltd. romanized |
| 2025/08/22New drug · Class 1 | 利福特尼唑胶囊 · No verified English nameCXHS2500103 | Dan Nuo Pharmaceuticals (Suzhou) Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized |
| 2025/08/22New drug · Class 1 | LPM516000152盐酸盐胶囊 · No verified English nameCXHL2500881 | Yan Tai Chuang He Bio Technology Co., Ltd. romanized |
| 2025/08/22New drug · Class 1 | LPM516000152盐酸盐胶囊 · No verified English nameCXHL2500880 | Yan Tai Chuang He Bio Technology Co., Ltd. romanized |
| 2025/08/21Import · Class 1 | Brenipatide注射液 · No verified English nameJXHL2500223 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/08/21Import · Class 1 | Brenipatide注射液 · No verified English nameJXHL2500222 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/08/21Import · Class 1 | Brenipatide注射液 · No verified English nameJXHL2500221 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/08/21Generic · Class 3 | Fexofenadine Hydrochloride TabletsCYHS2503071 | Zhi En Bio Technology Co., Ltd. romanized |
| 2025/08/21Generic · Class 3 | Fexofenadine Hydrochloride TabletsCYHS2503070 | Zhi En Bio Technology Co., Ltd. romanized |
| 2025/08/21Generic · Class 3 | 磷酸奥司他韦颗粒 · No verified English nameCYHS2503065 | Hunan Ou Ya Pharma Co., Ltd. romanized; Hunan Jia Heng Pharmaceutical Co., Ltd. romanized |
| 2025/08/21Generic · Class 3 | 甲磺酸亮丙瑞林注射乳剂 · No verified English nameCYHL2500148 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2025/08/21New drug · Class 1 | 注射用GenSci143 · No verified English nameCXSL2500728 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2025/08/20Import · Class 3.1 | 阿伏利尤单抗注射液 · No verified English nameJXSS2500109 | AstraZeneca AB; AstraZeneca Nijmegen B.V.; AstraZeneca Investment (China) Co. Ltd. |
| 2025/08/20Import · Class 1 | AZD2936 · No verified English nameJXSL2500156 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/08/20Import · Class 1 | Brenipatide注射液 · No verified English nameJXHL2500220 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/08/20Import · Class 1 | Brenipatide注射液 · No verified English nameJXHL2500219 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/08/20Import · Class 1 | Brenipatide注射液 · No verified English nameJXHL2500218 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/08/20Generic · Class 3 | Sodium Nitroprusside InjectionCYHS2503066 | Hua Run Shuang He Pharma Co., Ltd. romanized |
| 2025/08/20Generic · Class 3 | Potassium Chloride InjectionCYHS2503058 | Xian Jing Xi Shuang He Pharma Co., Ltd. romanized |
| 2025/08/20Generic · Class 3 | Magnesium Sulfate InjectionCYHS2503057 | Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized |
| 2025/08/20Generic · Class 3 | Magnesium Sulfate InjectionCYHS2503055 | Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized |
80 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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