YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 317 drug applications between 24 October 2025 and 30 October 2025 (data as of 14 November 2026 06:00). Of these, generic applications numbered 58, covering 42 drug names.
2025/10/24 – 2025/10/30
- New acceptances this week
- 317
- Drugs with new generic filings (by drug name, de-duplicated)
- 42
- Accepted this week, now under review
- 74
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
317filings, 58 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 170 |
| Generic | 58 |
| New drug | 53 |
| Import | 14 |
| Unspecified | 12 |
| Import re-registration | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 220 |
| TCM | 62 |
| Therapeutic biologic | 31 |
| Biologic | 2 |
| Unspecified | 1 |
| Prophylactic 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
42 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Finerenone Tablets | 5 | 3 | 69 |
| 2 | Fluticasone Propionate Cream | 2 | 2 | 12 |
| 3 | Crisaborole Ointment | 2 | 2 | 26 |
| 4 | Lidocaine and Tetracaine Cream | 2 | 2 | 2 |
| 5 | Metoclopramide Hydrochloride Injection | 2 | 2 | 6 |
| 6 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 7 | Cefditoren Pivoxil Granules | 2 | 1 | 18 |
| 8 | Vonoprazan Fumarate Tablets | 2 | 1 | 58 |
| 9 | Levothyroxine Sodium Tablets | 2 | 1 | 11 |
| 10 | Pregabalin Capsules | 2 | 1 | 12 |
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
196 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 | Qilu Pharmaceutical (Hainan) Co., Ltd | 8 | 3 | 0 |
| 3 | Jin Yao Da Ren Tang Group Co., Ltd. Long Shun Rong Pharmaceutical Factory romanized | 6 | 6 | 0 |
| 4 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 5 | 2 | 0 |
| 5 | Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 6 | Shi Yao Group En Bi Pu Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Ferring GmbH | 4 | 4 | 0 |
| 8 | Novartis Pharma Schweiz AG | 4 | 3 | 0 |
| 9 | McNeil Sweden AB | 4 | 1 | 0 |
| 10 | Nei Menggu Lan Tai Pharma Co., Ltd. romanized | 3 | 3 | 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
81 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/10/30Import · Class 3.1 | Nemolizumab注射液 · No verified English nameJXSL2500208 | Galderma SA; Q-Med International Trading (Shanghai) Co. Ltd |
| 2025/10/30Import · Class 1 | GSK6042981片 · No verified English nameJXHL2500334 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Company Limited |
| 2025/10/30New drug · Class 1.2 | 栀子西红花酸提取物(C2235) · No verified English nameCXZL2500106 | Zhejiang Jian Feng Pharma Co., Ltd. romanized |
| 2025/10/30New drug · Class 1 | 柯美奇拜单抗注射液 · No verified English nameCXSS2500116 | Shanghai Mai Ji Pharmaceuticals Co., Ltd. romanized; Ding Kang (Wuhan) Biopharmaceuticals Co., Ltd. romanized |
| 2025/10/30New drug · Class 1 | 注射用QLS5316 · No verified English nameCXSL2500934 | Qilu Pharmaceutical Co., Ltd. |
| 2025/10/30New drug · Class 2.2 | 布瑞哌唑口溶膜 · No verified English nameCXHS2500133 | Gansu Pu An Pharmaceutical Co., Ltd. romanized |
| 2025/10/30New drug · Class 2.2 | 布瑞哌唑口溶膜 · No verified English nameCXHS2500132 | Gansu Pu An Pharmaceutical Co., Ltd. romanized |
| 2025/10/30New drug · Class 2.2 | 布瑞哌唑口溶膜 · No verified English nameCXHS2500131 | Gansu Pu An Pharmaceutical Co., Ltd. romanized |
| 2025/10/30New drug · Class 1 | BGB-45035片 · No verified English nameCXHL2501194 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/10/30New drug · Class 1 | BGB-45035片 · No verified English nameCXHL2501193 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/10/30New drug · Class 1 | BGB-45035片 · No verified English nameCXHL2501192 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/10/30New drug · Class 1 | HW221043片 · No verified English nameCXHL2501191 | Hubei Biopharmaceuticals Industry Technology Research Institute Co., Ltd. romanized |
| 2025/10/30New drug · Class 1 | HW221043片 · No verified English nameCXHL2501190 | Hubei Biopharmaceuticals Industry Technology Research Institute Co., Ltd. romanized |
| 2025/10/29Import · Class 2.4 | JNJ-90301900 (NBTXR3)注射液 · No verified English nameJXHL2500335 | Johnson & Johnson Enterprise Innovation Inc.; Johnson & Johnson (China) Investment Ltd. |
| 2025/10/29Generic · Class 3 | 洛索洛芬钠颗粒 · No verified English nameCYHS2503827 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2025/10/29Generic · Class 3 | 富马酸酮替芬滴眼液 · No verified English nameCYHS2503822 | Guangdong Zhong Sheng Pharma Co., Ltd. romanized |
| 2025/10/29Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2503819 | Nanjing Hai Ke Rui Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Su Zhong Pharma Group Biopharmaceutical Co., Ltd. romanized |
| 2025/10/29Generic · Class 3 | 尿素[13C]呼气试验诊断试剂盒 · No verified English nameCYHL2500194 | Jiangsu Jin Bo Qi Tong Wei Su Technology Co., Ltd. romanized |
| 2025/10/29New drug · Class 1.2 | 栀子西红花酸提取物肠溶片(C2235片) · No verified English nameCXZL2500105 | Zhejiang Jian Feng Pharma Co., Ltd. romanized |
| 2025/10/29New drug · Class 1.1 | 慢痞消颗粒 · No verified English nameCXZL2500104 | Beijing Zhong Pharmaceuticals University romanized; Feng Huang Tian Dan (Beijing) Technology Co., Ltd. romanized |
| 2025/10/29New drug · Class 2.2 | 盐酸奥洛他定口服溶液 · No verified English nameCXHS2500130 | Hainan Wan Wei Pharmaceutical Co., Ltd. romanized |
| 2025/10/29New drug · Class 1 | GH31胶囊 · No verified English nameCXHL2501189 | Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2025/10/29New drug · Class 1 | GH31胶囊 · No verified English nameCXHL2501188 | Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2025/10/29New drug · Class 2.2 | XJN026鼻喷雾剂 · No verified English nameCXHL2501187 | Guangzhou Xin Ji Pharma Technology Co., Ltd. romanized |
| 2025/10/29New drug · Class 1 | YKYY018雾化吸入剂 · No verified English nameCXHL2501186 | Beijing Yue Kang Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized |
| 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 |
51 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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