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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 337 drug applications between 29 December 2025 and 4 January 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 83, covering 56 drug names.

2025/12/29 – 2026/01/04

Period
2025/12/29 to 2026/01/04, 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
337
Drugs with new generic filings (by drug name, de-duplicated)
56
Accepted this week, now under review
89

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

337filings, 83 of them generic

By application type

Application typeFilings
Supplement121
New drug103
Generic83
Import16
Unspecified8
Import re-registration6

By drug type

Drug typeFilings
Chemical drug204
TCM72
Therapeutic biologic57
Prophylactic biologic3
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

56 drugs with new generic filings; top 10 listed

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

197 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Nei Menggu Da Tang Pharma Co., Ltd. romanized28260
2Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized610
3Chongqing Zhang Xin Pharmaceutical Co., Ltd. romanized550
4Nanjing Rui Chu Pharmaceuticals Co., Ltd. romanized520
5Dan Dong Pharma Group Co., Ltd. romanized440
6Zhejiang AngLiKang Pharmaceutical CO.,LTD.444
7Novartis Pharma AG430
8Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized434
9Excella GmbH & Co. KG420
10Bristol-Myers Squibb Company410

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

142 this week

AcceptedDrugApplicants
2026/01/04Import · Class 2.4 盐酸芬氟拉明口服溶液 · No verified English nameJXHL2600001 UCB Pharma S.A.; UCB Trading (Shanghai) Co. Ltd
2026/01/04Generic · Class 3 尿素[14C]胶囊 · No verified English nameCYHL2500237 Shenzhen Shi Fu Rui Kang Technology Co., Ltd. romanized
2026/01/04New drug · Class 1 QLH2405注射液 · No verified English nameCXSL2600006 Qilu Pharmaceutical Co., Ltd.
2026/01/04New drug · Class 1.2 Argo-3002 · No verified English nameCXSL2600005 A Ge Na Biopharmaceutical Co., Ltd. romanized; Guangzhou Shi Rui Bo Bio Technology Co., Ltd. romanized
2026/01/04New drug · Class 1 OVV-01注射液 · No verified English nameCXSL2501188 Shanghai Rong Rui Pharmaceuticals Technology Co., Ltd. romanized
2026/01/04New drug · Class 1 OVV-01注射液(静脉) · No verified English nameCXSL2501187 Shanghai Rong Rui Pharmaceuticals Technology Co., Ltd. romanized
2026/01/04New drug · Class 1 注射用YK012 · No verified English nameCXSL2501186 Yi Ke Si Te (Beijing) Pharmaceuticals Technology Development Co., Ltd. romanized
2026/01/04New drug · Class 1 注射用YK012 · No verified English nameCXSL2501185 Yi Ke Si Te (Beijing) Pharmaceuticals Technology Development Co., Ltd. romanized
2026/01/04New drug · Class 1 DSL201注射液 · No verified English nameCXSL2501184 Suzhou Xing He Di Sai Bio Technology Co., Ltd. romanized
2026/01/04New drug · Class 1 人脐带间充质基质细胞注射液 · No verified English nameCXSL2501180 Jing Dong Fang Zai Sheng Yi Xue Technology Co., Ltd. romanized
2026/01/04New drug · Class 1 FL115注射液(皮下注射) · No verified English nameCXSL2501179 Suzhou Fu Rong Bio Technology Co., Ltd. romanized
2026/01/04New drug · Class 2.4 Dexamethasone Palmitate InjectionCXHS2500168 Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized
2026/01/04New drug · Class 2.2 盐酸尼卡地平控释片 · No verified English nameCXHL2501539 Beijing Wu He Bo Ao Pharma Co., Ltd. romanized; Zhongguo Yi Xue Ke College Drug Research Institute romanized; Guangxi Wu He Bo Ao Pharma Co., Ltd. romanized
2026/01/04New drug · Class 1 HSK46575片 · No verified English nameCXHL2501538 Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized
2026/01/04New drug · Class 1 HSK46575片 · No verified English nameCXHL2501537 Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized
2026/01/04New drug · Class 1 HSK46575片 · No verified English nameCXHL2501536 Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized
2026/01/04New drug · Class 1 LDR2515注射液 · No verified English nameCXHL2501532 Chengdu Xian Yan Bio Technology Co., Ltd. romanized
2026/01/04New drug · Class 1 WT-1108片 · No verified English nameCXHL2501531 Hangzhou Wei Tan Pharmaceuticals Technology Co., Ltd. romanized
2026/01/04New drug · Class 1 WT-1108片 · No verified English nameCXHL2501530 Hangzhou Wei Tan Pharmaceuticals Technology Co., Ltd. romanized
2026/01/04New drug · Class 2.2 KLA578-2贴剂 · No verified English nameCXHL2501529 Sichuan Kelun Pharmaceutical Co., Ltd.
2026/01/04New drug · Class 2.2 KLA578-2贴剂 · No verified English nameCXHL2501528 Sichuan Kelun Pharmaceutical Co., Ltd.
2026/01/04New drug · Class 1 ABP-745片 · No verified English nameCXHL2501525 Hangzhou Xin Yuan Su Pharma Co., Ltd. romanized
2026/01/01New drug · Class 1 LM-168注射液 · No verified English nameCXSL2501178 Li Xin Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/01/01New drug · Class 2.3 海博麦布阿托伐他汀钙片 · No verified English nameCXHL2501524 Han Hui Pharmaceutical Co., Ltd. romanized
2026/01/01New drug · Class 1 SYN818片 · No verified English nameCXHL2501523 Hangzhou Sheng Yu Biopharmaceuticals Technology Co., Ltd. romanized
2026/01/01New drug · Class 1 SYN818片 · No verified English nameCXHL2501522 Hangzhou Sheng Yu Biopharmaceuticals Technology Co., Ltd. romanized
2025/12/31Import · Class 2.2 Nipocalimab注射液 · No verified English nameJXSL2500251 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2025/12/31Import · Class 1 BHV-8000缓释片 · No verified English nameJXHL2500406 Biohaven Therapeutics Ltd.; Hangzhou Highlightll Pharmaceutical Co. Ltd
2025/12/31Import · Class 1 BHV-8000缓释片 · No verified English nameJXHL2500405 Biohaven Therapeutics Ltd.; Hangzhou Highlightll Pharmaceutical Co. Ltd
2025/12/31Import · Class 2.4 BMS-986510胶囊 · No verified English nameJXHL2500404 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.

112 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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