YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 404 drug applications between 30 December 2025 and 5 January 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 109, covering 75 drug names.

2025/12/30 – 2026/01/05

Period
2025/12/30 to 2026/01/05, 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
404
Drugs with new generic filings (by drug name, de-duplicated)
75
Accepted this week, now under review
121

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, 109 of them generic

By application type

Application typeFilings
Supplement164
Generic109
New drug104
Import14
Unspecified8
Import re-registration5

By drug type

Drug typeFilings
Chemical drug244
TCM92
Therapeutic biologic63
Biologic4
Prophylactic 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

75 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

225 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Nei Menggu Da Tang Pharma Co., Ltd. romanized33310
2Sichuan Tian De Pharmaceutical Co., Ltd. romanized990
3Janssen-Cilag International NV810
4Guangdong Wan Nian Qing Pharmaceutical Co., Ltd. romanized660
5Heng Ji Pharmaceuticals (Shanghai) Co., Ltd. romanized610
6Nanjing Rui Chu Pharmaceuticals Co., Ltd. romanized520
7Beijing Foyou Pharma CO.,LTD443
8Zhejiang AngLiKang Pharmaceutical CO.,LTD.444
9Shen Wei Pharma (Zhang Jia Kou) Co., Ltd. romanized440
10Janssen Research & Development LLC430

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

144 this week

AcceptedDrugApplicants
2026/01/05Import · Class 2.1 仑卡奈单抗注射液(皮下注射) · No verified English nameJXSS2600001 Eisai Inc.; Terumo Corporation Kofu Factory; Eisai China Inc.
2026/01/05Import · Class 2.1 注射用贝林妥欧单抗(皮下注射) · No verified English nameJXSL2600001 Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd.
2026/01/05Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2600030 Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized
2026/01/05Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2600029 Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized
2026/01/05Generic · Class 3 复方匹可硫酸钠颗粒 · No verified English nameCYHS2600022 Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized; Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized
2026/01/05Generic · Class 3 Voglibose Orally Dispersing TabletsCYHS2600017 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Jin Zhou Ao Hong Pharma Co., Ltd. romanized
2026/01/05Generic · Class 3 Probucol TabletsCYHS2600014 Beijing Foyou Pharma CO.,LTD
2026/01/05Generic · Class 3 枸橼酸西地那非口溶膜 · No verified English nameCYHS2600013 Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized; Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized
2026/01/05Generic · Class 3 盐酸甲氧氯普胺口服溶液 · No verified English nameCYHS2600005 Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Tong Da Pharma Co., Ltd. romanized
2026/01/05New drug · Class 1 注射用HMPL-A580 · No verified English nameCXSL2600011 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized
2026/01/05New drug · Class 1 CT0596 CAR T细胞注射液 · No verified English nameCXSL2600004 You Kai Ze Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2026/01/05New drug · Class 1 CT0596 CAR T细胞注射液 · No verified English nameCXSL2600003 You Kai Ze Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2026/01/05New drug · Class 1 注射用IN30758 · No verified English nameCXSL2600002 Ying Shi Bio Technology (Shenzhen) Co., Ltd. romanized
2026/01/05New drug · Class 3.3 重组抗PD-1人源化单克隆抗体注射液 · No verified English nameCXSL2600001 Fu Xing Han Lin (Chengdu) Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized
2026/01/05New drug · Class 2.3 西格列他钠二甲双胍缓释片 · No verified English nameCXHL2600017 Shenzhen Wei Xin Bio Technology Co., Ltd. romanized; Chengdu Wei Xin Pharma Co., Ltd. romanized
2026/01/05New drug · Class 2.3 西格列他钠二甲双胍缓释片 · No verified English nameCXHL2600016 Shenzhen Wei Xin Bio Technology Co., Ltd. romanized; Chengdu Wei Xin Pharma Co., Ltd. romanized
2026/01/05New drug · Class 2.2 CBT-009眼用乳液 · No verified English nameCXHL2600011 Bo Kang Shi Yun Biopharmaceuticals Technology (Suzhou) Co., Ltd. romanized
2026/01/05New drug · Class 2.4 注射用盐酸伊吡诺司他 · No verified English nameCXHL2600010 Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized
2026/01/05New drug · Class 1 FH001片 · No verified English nameCXHL2600009 Heng Ji Pharmaceuticals (Shanghai) Co., Ltd. romanized
2026/01/05New drug · Class 1 FH001片 · No verified English nameCXHL2600008 Heng Ji Pharmaceuticals (Shanghai) Co., Ltd. romanized
2026/01/05New drug · Class 1 FH001片 · No verified English nameCXHL2600007 Heng Ji Pharmaceuticals (Shanghai) Co., Ltd. romanized
2026/01/05New drug · Class 1 FH001片 · No verified English nameCXHL2600006 Heng Ji Pharmaceuticals (Shanghai) Co., Ltd. romanized
2026/01/05New drug · Class 1 FH001片 · No verified English nameCXHL2600005 Heng Ji Pharmaceuticals (Shanghai) Co., Ltd. romanized
2026/01/05New drug · Class 1 FH001片 · No verified English nameCXHL2600004 Heng Ji Pharmaceuticals (Shanghai) Co., Ltd. romanized
2026/01/05New drug · Class 1 FXS0683片 · No verified English nameCXHL2600003 Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized
2026/01/05New drug · Class 1 FXS0683片 · No verified English nameCXHL2600002 Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized
2026/01/05New drug · Class 1 FXS0683片 · No verified English nameCXHL2600001 Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized
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.

114 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.