YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 404 drug applications between 23 August 2025 and 29 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 102, covering 71 drug names.
2025/08/23 – 2025/08/29
- New acceptances this week
- 404
- Drugs with new generic filings (by drug name, de-duplicated)
- 71
- Accepted this week, now under review
- 88
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
404filings, 102 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 187 |
| Generic | 102 |
| New drug | 73 |
| Import | 32 |
| Unspecified | 6 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 286 |
| TCM | 63 |
| Therapeutic biologic | 49 |
| Biologic | 3 |
| Prophylactic biologic | 2 |
| Unspecified | 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
71 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sufentanil Citrate Injection | 4 | 1 | 0 |
| 2 | 瑞维那新吸入溶液 · No verified English name | 3 | 3 | 53 |
| 3 | Apalutamide Tablets | 3 | 3 | 18 |
| 4 | Ambroxol Hydrochloride Injection | 3 | 1 | 9 |
| 5 | Memantine Hydrochloride OD Tablets | 3 | 1 | 2 |
| 6 | Polidocanol Injection | 3 | 1 | 23 |
| 7 | Isavuconazonium Sulfate for Injection | 2 | 2 | 15 |
| 8 | 甘油磷酸钠注射液 · No verified English name | 2 | 2 | 7 |
| 9 | Iguratimod Tablets | 2 | 2 | 23 |
| 10 | 利伐沙班口崩片 · No verified English name | 2 | 1 | 4 |
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
225 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Eli Lilly and Company | 17 | 2 | 0 |
| 2 | Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized | 12 | 9 | 0 |
| 3 | NAPP PHARMACEUTICALS LIMITED | 9 | 1 | 0 |
| 4 | CSPC OUYI PHARMACEUTICAL CO., LTD. | 7 | 5 | 5 |
| 5 | Janssen-Cilag International NV | 7 | 3 | 0 |
| 6 | Gui Lin Hua Run Tian He Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 7 | AstraZeneca AB | 5 | 2 | 0 |
| 8 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 5 | 2 | 0 |
| 9 | Qilu Pharmaceutical Co., Ltd. | 5 | 1 | 0 |
| 10 | Beijing Tong Ren Tang Pharmaceutical Co., Ltd. romanized | 4 | 4 | 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 |
|---|---|---|
| 2025/08/29Generic · Class 3 | MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2503175 | Hebei Hua Chen Pharma Group Co., Ltd. romanized |
| 2025/08/29Generic · Class 3 | Milnacipran Hydrochloride TabletsCYHS2503173 | Bai Yun Shandong Tai Shang Qiu Pharma Co., Ltd. romanized |
| 2025/08/29Generic · Class 3 | 盐酸地尔硫?控释胶囊 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2503164 | Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized |
| 2025/08/29Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2503163 | Qian Hai Shi De Tang (He Bi) Pharmaceutical Co., Ltd. romanized |
| 2025/08/29Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2503162 | Qian Hai Shi De Tang (He Bi) Pharmaceutical Co., Ltd. romanized |
| 2025/08/29Generic · Class 3 | Leuprorelin Acetate Microspheres for InjectionCYHL2500159 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/08/29Generic · Class 3 | Ketoprofen PatchesCYHL2500157 | HUNAN WARRANT PHARMACEUTICAL CO.,LTD |
| 2025/08/29New drug · Class 1.1 | 保精片 · No verified English nameCXZL2500069 | Su Zhong Pharma Group Co., Ltd. romanized; Jiangsu Su Zhong Pharma Research Institute Co., Ltd. romanized |
| 2025/08/29New drug · Class 1.3 | 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2500749 | Beijing Ke Xing Zhong Wei Bio Technology Co., Ltd. romanized; Ke Xing (Da Lian) Yi Miao Technology Co., Ltd. romanized |
| 2025/08/29New drug · Class 1 | ARC001滴鼻液 · No verified English nameCXSL2500748 | Name not romanized |
| 2025/08/29New drug · Class 1 | ARC001注射液 · No verified English nameCXSL2500747 | Name not romanized |
| 2025/08/29New drug · Class 1 | AK152注射液 · No verified English nameCXSL2500746 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2025/08/29New drug · Class 1 | JNJ-88998377口服片 · No verified English nameCXHL2500927 | Qiang Sheng (Zhongguo) Investment Co., Ltd. romanized |
| 2025/08/29New drug · Class 1 | JNJ-88998377口服片 · No verified English nameCXHL2500926 | Qiang Sheng (Zhongguo) Investment Co., Ltd. romanized |
| 2025/08/29New drug · Class 1 | JNJ-88998377口服片 · No verified English nameCXHL2500925 | Qiang Sheng (Zhongguo) Investment Co., Ltd. romanized |
| 2025/08/29New drug · Class 1 | JMKX000189片 · No verified English nameCXHL2500924 | Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/08/29New drug · Class 1 | JMKX000189片 · No verified English nameCXHL2500923 | Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/08/29New drug · Class 1 | JMKX000189片 · No verified English nameCXHL2500922 | Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/08/29New drug · Class 1 | XNW34017片 · No verified English nameCXHL2500921 | Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/08/29New drug · Class 1 | ANS014004片 · No verified English nameCXHL2500920 | Beijing An Shi Bio Technology Co., Ltd. romanized |
| 2025/08/29New drug · Class 1 | XNW34017片 · No verified English nameCXHL2500919 | Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/08/29New drug · Class 1 | ANS014004片 · No verified English nameCXHL2500918 | Beijing An Shi Bio Technology Co., Ltd. romanized |
| 2025/08/29New drug · Class 1 | ST-01156胶囊 · No verified English nameCXHL2500917 | Wan Chun Hong Ji (Da Lian) Pharmaceuticals Co., Ltd. romanized |
| 2025/08/29New drug · Class 1 | ST-01156胶囊 · No verified English nameCXHL2500916 | Wan Chun Hong Ji (Da Lian) Pharmaceuticals Co., Ltd. romanized |
| 2025/08/29New drug · Class 1 | ST-01156胶囊 · No verified English nameCXHL2500915 | Wan Chun Hong Ji (Da Lian) Pharmaceuticals Co., Ltd. romanized |
| 2025/08/29New drug · Class 1 | ST-01156胶囊 · No verified English nameCXHL2500914 | Wan Chun Hong Ji (Da Lian) Pharmaceuticals Co., Ltd. romanized |
| 2025/08/29New drug · Class 2.4 | 富马酸泰吉利定注射液 · No verified English nameCXHL2500913 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/08/29New drug · Class 2.4 | 富马酸泰吉利定注射液 · No verified English nameCXHL2500912 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/08/29New drug · Class 2.2 | JL4083吸入溶液 · No verified English nameCXHL2500911 | Sichuan Jian Lin Pharma Co., Ltd. romanized |
| 2025/08/29New drug · Class 2.2 | JL4083吸入溶液 · No verified English nameCXHL2500910 | Sichuan Jian Lin 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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