YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 291 drug applications between 17 April 2025 and 23 April 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 77, covering 63 drug names.
2025/04/17 – 2025/04/23
- New acceptances this week
- 291
- Drugs with new generic filings (by drug name, de-duplicated)
- 63
- Accepted this week, now under review
- 34
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
291filings, 77 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 128 |
| Generic | 77 |
| New drug | 50 |
| Import | 17 |
| Import re-registration | 14 |
| Unspecified | 2 |
| Drug-device combination | 2 |
| Drug-device combination product | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 206 |
| TCM | 49 |
| Therapeutic biologic | 33 |
| Prophylactic biologic | 2 |
| 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
63 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Riociguat Tablets | 3 | 1 | 4 |
| 2 | Ruxolitinib Phosphate Tablets | 3 | 1 | 27 |
| 3 | 草酸艾司西酞普兰口服溶液 · No verified English name | 2 | 2 | 11 |
| 4 | 蒙脱石混悬液 · No verified English name | 2 | 2 | 31 |
| 5 | Tacrolimus Ointment | 2 | 1 | 6 |
| 6 | 布美他尼片 · No verified English name | 2 | 1 | 8 |
| 7 | Cariprazine hydrochloride Capsules | 2 | 1 | 3 |
| 8 | Promethazine Hydrochloride Injection | 2 | 1 | 11 |
| 9 | Propranolol Hydrochloride Injection | 2 | 1 | 4 |
| 10 | Mivacurium Chloride Injection | 2 | 1 | 3 |
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
176 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 9 | 3 | 0 |
| 2 | Eli Lilly and Company | 6 | 1 | 0 |
| 3 | Kowa Company Ltd. | 5 | 1 | 0 |
| 4 | Jin Yao Da Ren Tang Group Co., Ltd. Long Shun Rong Pharmaceutical Factory romanized | 4 | 4 | 0 |
| 5 | Rong Kang Group Guangxi Kang Shi Yuan Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Guizhou Bei Bi Qiang Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Janssen-Cilag International NV | 4 | 2 | 0 |
| 8 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | Qilu Pharmaceutical Co., Ltd. | 4 | 2 | 3 |
| 10 | AstraZeneca UK Limited | 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
97 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/04/23Import · Class 1 | 尼卡利单抗注射液 · No verified English nameJXSS2500050 | Janssen-Cilag International NV; Vetter Pharma-Fertigung GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd. |
| 2025/04/23Import · Class 1 | 尼卡利单抗注射液 · No verified English nameJXSS2500049 | Janssen-Cilag International NV; Vetter Pharma-Fertigung GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd. |
| 2025/04/23Import · Class 1 | Relatlimab注射液 · No verified English nameJXSL2500063 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/04/23Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500093 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/04/23Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500092 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/04/23Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500091 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/04/23Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500090 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/04/23Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500089 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/04/23Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500088 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/04/23Import · Class 1 | 注射用KSP-1007-05 · No verified English nameJXHL2500087 | Sumitomo Pharma Co. Ltd. |
| 2025/04/23Generic · Class 3 | Gliclazide TabletsCYHS2501529 | Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized |
| 2025/04/23Generic · Class 3 | 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2501528 | Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized |
| 2025/04/23Generic · Class 3 | Mesalazine Gastro-Resistant Prolonged-Release GranulesCYHS2501527 | Hua Yi Tai Kang Pharma Co., Ltd. romanized |
| 2025/04/23Generic · Class 3 | Mesalazine Gastro-Resistant Prolonged-Release GranulesCYHS2501526 | Hua Yi Tai Kang Pharma Co., Ltd. romanized |
| 2025/04/23Generic · Class 3 | 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2501519 | Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized |
| 2025/04/23New drug · Class 1.4 | 重组三价人乳头瘤病毒(16/18/58型)疫苗(大肠杆菌) · No verified English nameCXSS2500048 | Kang Le Wei Shi (Kunming) Bio Technology Co., Ltd. romanized |
| 2025/04/23New drug · Class 2.2 | 贝莫苏拜单抗注射液 · No verified English nameCXSS2500047 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2025/04/23New drug · Class 2.2 | 贝莫苏拜单抗注射液 · No verified English nameCXSS2500046 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2025/04/23New drug · Class 1 | 注射用QLS5133 · No verified English nameCXSL2500326 | Qilu Pharmaceutical Co., Ltd. |
| 2025/04/23New drug · Class 1 | GR1803注射液 · No verified English nameCXSL2500325 | Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized; Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized |
| 2025/04/23New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHS2500035 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2025/04/23New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHS2500034 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2025/04/23New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHS2500033 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2025/04/23New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHS2500032 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2025/04/22Import · Class 1 | SAR442970注射液 · No verified English nameJXSL2500062 | Sanofi-Aventis Recherche & Développement; Fortrea Pharmaceutical Research and Development (Beijing) Co. Ltd. |
| 2025/04/22Import · Class 2.1 | Tarlatamab · No verified English nameJXSL2500061 | Amgen Inc.; BeiGene (Beijing) Co. Ltd |
| 2025/04/22Generic · Class 3 | Pregabalin Oral SolutionCYHS2501516 | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. |
| 2025/04/22Generic · Class 3 | 左卡尼汀咀嚼片 · No verified English nameCYHS2501515 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. |
| 2025/04/22Generic · Class 3 | 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2501513 | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized |
| 2025/04/22Generic · Class 3 | 盐酸甲氧氯普胺口服溶液 · No verified English nameCYHS2501512 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized |
67 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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