YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 338 drug applications between 22 October 2025 and 28 October 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 67, covering 50 drug names.
2025/10/22 – 2025/10/28
- New acceptances this week
- 338
- Drugs with new generic filings (by drug name, de-duplicated)
- 50
- Accepted this week, now under review
- 90
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, 67 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 177 |
| Generic | 67 |
| New drug | 67 |
| Import | 15 |
| Import re-registration | 7 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 231 |
| TCM | 71 |
| Therapeutic biologic | 32 |
| Prophylactic biologic | 2 |
| Unspecified | 1 |
| Biologic | 1 |
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
50 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Glucosamine Sulfate Capsules | 3 | 3 | 51 |
| 2 | Dapagliflozin Tablets | 3 | 2 | 84 |
| 3 | Finerenone Tablets | 3 | 2 | 69 |
| 4 | Fluticasone Propionate Cream | 2 | 2 | 12 |
| 5 | Lidocaine and Tetracaine Cream | 2 | 2 | 2 |
| 6 | Iguratimod Tablets | 2 | 2 | 23 |
| 7 | Clindamycin Injection | 2 | 1 | 4 |
| 8 | Cefditoren Pivoxil Granules | 2 | 1 | 18 |
| 9 | Levothyroxine Sodium Tablets | 2 | 1 | 12 |
| 10 | 注射用托伐普坦磷酸钠 · No verified English name | 2 | 1 | 15 |
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
205 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Xinjiang Hua Shi Dan Pharma Co., Ltd. romanized | 19 | 2 | 0 |
| 2 | Jiangsu Si Jia Wei Kang Pharmaceuticals Technology Co., Ltd. romanized | 9 | 1 | 0 |
| 3 | Qilu Pharmaceutical (Hainan) Co., Ltd | 8 | 3 | 0 |
| 4 | Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized | 7 | 6 | 0 |
| 5 | Jin Yao Da Ren Tang Group Co., Ltd. Long Shun Rong Pharmaceutical Factory romanized | 6 | 6 | 0 |
| 6 | Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 6 | 5 | 2 |
| 7 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 0 |
| 8 | Shi Yao Group En Bi Pu Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 9 | McNeil Sweden AB | 4 | 1 | 0 |
| 10 | Shanghai Yi Shi Pharmaceuticals 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
102 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/10/28Import · Class 3.1 | 尼塔奇单抗注射液 · No verified English nameJXSS2500135 | Joint Stock Company“BIOCAD”(JSC“BIOCAD”); SPH-BIOCAD Biopharmaceuticals (SH) Co. Ltd. |
| 2025/10/28Import · Class 1 | Zilebesiran注射液 · No verified English nameJXHL2500332 | Alnylam Pharmaceuticals Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd |
| 2025/10/28Generic · Class 3 | 复方聚乙二醇电解质散(II) · No verified English nameCYHS2503815 | Chongqing Xin He Bio Technology Co., Ltd. romanized; Chongqing Ke Rui Nan Hai Pharmaceutical Co., Ltd. romanized |
| 2025/10/28Generic · Class 3 | 蔗糖羟基氧化铁颗粒 · No verified English nameCYHS2503810 | Hunan Ming Rui Pharmaceutical Co., Ltd. romanized |
| 2025/10/28Generic · Class 3 | Bromhexine Hydrochloride Solution For InhalationCYHS2503805 | Jiangxi Yi You Pharma Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized |
| 2025/10/28Generic · Class 3 | Sodium Nitroprusside InjectionCYHS2503804 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2025/10/28Generic · Class 3 | Lidocaine and Tetracaine CreamCYHL2500193 | Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/10/28Generic · Class 3 | Lidocaine and Tetracaine CreamCYHL2500192 | Hubei Heng An Fu Lin Pharma Co., Ltd. romanized |
| 2025/10/28New drug · Class 1.1 | 清血败毒丸 · No verified English nameCXZL2500103 | Jiangsu Zhong Yong Hong Rui Pharmaceutical Co., Ltd. romanized |
| 2025/10/28New drug · Class 2.2; 2.4 | 注射用重组A型肉毒毒素 · No verified English nameCXSL2500933 | Jun He Meng Biopharmaceutical (Tong Hua) Co., Ltd. romanized |
| 2025/10/28New drug · Class 2.2; 2.4 | 注射用重组A型肉毒毒素 · No verified English nameCXSL2500932 | Jun He Meng Biopharmaceutical (Tong Hua) Co., Ltd. romanized |
| 2025/10/28New drug · Class 2.2; 2.4 | 注射用重组A型肉毒毒素 · No verified English nameCXSL2500931 | Jun He Meng Biopharmaceutical (Tong Hua) Co., Ltd. romanized |
| 2025/10/28New drug · Class 1 | 注射用SKB105 · No verified English nameCXSL2500930 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2025/10/28New drug · Class 1 | 注射用重组人白介素22-Fc融合蛋白 · No verified English nameCXSL2500929 | Yi Yi Biopharmaceuticals Kai Fa (Shanghai) Co., Ltd. romanized; Yi Yi Biopharmaceutical (Beijing) Co., Ltd. romanized |
| 2025/10/28New drug · Class 1 | 重组人GM-CSF溶瘤II型单纯疱疹病毒(OH2)注射液(Vero细胞) · No verified English nameCXSL2500928 | Bin Hui Bio Technology (Beijing) Co., Ltd. romanized |
| 2025/10/28New drug · Class 1 | 注射用7MW3711 · No verified English nameCXSL2500927 | Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized |
| 2025/10/28New drug · Class 1 | 注射用JS207 · No verified English nameCXSL2500926 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/10/28New drug · Class 1 | 宫血间充质干细胞注射液 · No verified English nameCXSL2500925 | Zhejiang Sheng Chuang Jing Zhun Medical Technology Co., Ltd. romanized |
| 2025/10/28New drug · Class 2.4 | 氟唑帕利胶囊 · No verified English nameCXHS2500129 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/10/28New drug · Class 1 | RDc001片 · No verified English nameCXHL2501185 | Henan Sheng Rui Da Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/10/28New drug · Class 1 | HRS-7535片 · No verified English nameCXHL2501184 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/10/28New drug · Class 1 | HRS-7535片 · No verified English nameCXHL2501183 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/10/28New drug · Class 1 | HRS-7535片 · No verified English nameCXHL2501182 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/10/28New drug · Class 2.2 | 泊沙康唑分散片 · No verified English nameCXHL2501181 | Beijing De Li Fu Rui Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/10/28New drug · Class 2.2 | LHH-2201颗粒 · No verified English nameCXHL2501180 | Hebei Long Hai Pharma Co., Ltd. romanized |
| 2025/10/28New drug · Class 2.2 | LHH-2201颗粒 · No verified English nameCXHL2501179 | Hebei Long Hai Pharma Co., Ltd. romanized |
| 2025/10/28New drug · Class 2.2 | LHH-2201颗粒 · No verified English nameCXHL2501178 | Hebei Long Hai Pharma Co., Ltd. romanized |
| 2025/10/28New drug · Class 1 | YKYY018雾化吸入剂 · No verified English nameCXHL2501177 | Beijing Yue Kang Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/10/28New drug · Class 1 | HSK44459片 · No verified English nameCXHL2501176 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized |
| 2025/10/28New drug · Class 2.2 | 乙磺酸尼达尼布吸入粉雾剂 · No verified English nameCXHL2501175 | Shi Yao Group En Bi Pu Pharma Co., Ltd. romanized; Beijing Kang Chuang Lian Biopharmaceutical Technology Research Co., Ltd. romanized |
72 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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