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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

Period
2025/04/17 to 2025/04/23, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
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 typeFilings
Supplement128
Generic77
New drug50
Import17
Import re-registration14
Unspecified2
Drug-device combination2
Drug-device combination product1

By drug type

Drug typeFilings
Chemical drug206
TCM49
Therapeutic biologic33
Prophylactic biologic2
Biologic1

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

#DrugNew generic filingsFiling companiesUnder review, all years
1Riociguat Tablets314
2Ruxolitinib Phosphate Tablets3127
3草酸艾司西酞普兰口服溶液 · No verified English name2211
4蒙脱石混悬液 · No verified English name2231
5Tacrolimus Ointment216
6布美他尼片 · No verified English name218
7Cariprazine hydrochloride Capsules213
8Promethazine Hydrochloride Injection2111
9Propranolol Hydrochloride Injection214
10Mivacurium Chloride Injection213

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)FilingsDrugsGeneric
1Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized930
2Eli Lilly and Company610
3Kowa Company Ltd.510
4Jin Yao Da Ren Tang Group Co., Ltd. Long Shun Rong Pharmaceutical Factory romanized440
5Rong Kang Group Guangxi Kang Shi Yuan Pharmaceutical Co., Ltd. romanized440
6Guizhou Bei Bi Qiang Pharma Co., Ltd. romanized440
7Janssen-Cilag International NV420
8Jiangsu Kang Yuan Pharma Co., Ltd. romanized420
9Qilu Pharmaceutical Co., Ltd.423
10AstraZeneca UK Limited410

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

AcceptedDrugApplicants
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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