YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 399 drug applications between 31 December 2025 and 6 January 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 95, covering 71 drug names.

2025/12/31 – 2026/01/06

Period
2025/12/31 to 2026/01/06, 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
399
Drugs with new generic filings (by drug name, de-duplicated)
71
Accepted this week, now under review
118

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

399filings, 95 of them generic

By application type

Application typeFilings
Supplement179
Generic95
New drug94
Import19
Unspecified11
Import re-registration1

By drug type

Drug typeFilings
Chemical drug234
TCM83
Therapeutic biologic72
Biologic6
Prophylactic biologic4

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

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

234 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Nei Menggu Da Tang Pharma Co., Ltd. romanized14140
2Sichuan Tian De Pharmaceutical Co., Ltd. romanized990
3Gan Li Pharma Shandong Co., Ltd. romanized910
4Novartis Pharma AG850
5Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized820
6Janssen-Cilag International NV810
7Guangdong Wan Nian Qing Pharmaceutical Co., Ltd. romanized660
8Heng Ji Pharmaceuticals (Shanghai) Co., Ltd. romanized610
9Nanjing Rui Chu Pharmaceuticals Co., Ltd. romanized520
10Beijing Foyou Pharma CO.,LTD443

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

133 this week

AcceptedDrugApplicants
2026/01/06Import · Class 1 177Lu-PSMA I&T注射液 · No verified English nameJXHL2600006 Curium US LLC; Beijing Regitrans Consulting Co. Ltd.
2026/01/06Import · Class 2.4 ABL001片 · No verified English nameJXHL2600005 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/01/06Import · Class 2.4 ABL001胶囊装颗粒 · No verified English nameJXHL2600004 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/01/06Import · Class 2.4 ABL001胶囊装颗粒 · No verified English nameJXHL2600003 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/01/06Import · Class 2.4 ABL001胶囊装颗粒 · No verified English nameJXHL2600002 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/01/06Generic · Class 3 Promethazine Hydrochloride InjectionCYHS2600044 Kang Pu Pharma Co., Ltd. romanized
2026/01/06Generic · Class 3 Promethazine Hydrochloride InjectionCYHS2600043 Kang Pu Pharma Co., Ltd. romanized
2026/01/06Generic · Class 3 Nalbuphine Hydrochloride InjectionCYHS2600037 Guo Yao Group Gong Ye Co., Ltd. Lang Fang Branch romanized
2026/01/06Generic · Class 3 利非司特滴眼液 · No verified English nameCYHL2600003 Chengdu Tian Xing Zhi Yuan Bio Technology Co., Ltd. romanized
2026/01/06Generic · Class 3 Relugolix TabletsCYHL2600002 Shandong Fu Rui Da Pharmaceuticals Group Co., Ltd. romanized
2026/01/06New drug · Class 3.1 一贯煎颗粒 · No verified English nameCXZS2600001 Anhui Hua Run Jin Chan Pharma Co., Ltd. romanized
2026/01/06New drug · Class 1.1 消炎解毒合剂 · No verified English nameCXZL2600001 Hubei Yi En Pharma Co., Ltd. romanized
2026/01/06New drug · Class 3.4 人凝血酶原复合物 · No verified English nameCXSS2600001 Guo Yao Group Guizhou Biopharmaceutical Co., Ltd. romanized
2026/01/06New drug · Class 1 SSGJ-716注射液 · No verified English nameCXSL2600014 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2026/01/06New drug · Class 3.2 抗D人免疫球蛋白 · No verified English nameCXSL2600013 Xinjiang De Yuan Bio Gong Cheng Co., Ltd. romanized
2026/01/06New drug · Class 1 注射用RGL-236 · No verified English nameCXSL2600012 Shanghai Rui Hong Di Pharmaceuticals Co., Ltd. romanized; Guangzhou Rui Ling Pharmaceuticals Co., Ltd. romanized
2026/01/06New drug · Class 3.3 PJ021注射液 · No verified English nameCXSL2600010 Chongqing Pai Jin Bio Technology Co., Ltd. romanized
2026/01/06New drug · Class 1 注射用IMM0306 · No verified English nameCXSL2600009 Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/01/06New drug · Class 3.3 JMT205注射液 · No verified English nameCXSL2600008 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2026/01/06New drug · Class 1 SSS55注射液 · No verified English nameCXSL2600007 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2026/01/06New drug · Class 1 HSK39297片 · No verified English nameCXHS2600002 Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized; Hai Si Ke Pharmaceutical (Mei Shan) Co., Ltd. romanized
2026/01/06New drug · Class 2.3 缬沙坦左氨氯地平片 · No verified English nameCXHS2600001 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Jiangsu He Chen Pharma Co., Ltd. romanized
2026/01/06New drug · Class 1 SYH2082注射液 · No verified English nameCXHL2600019 Beijing Kang Chuang Lian Biopharmaceutical Technology Research Co., Ltd. romanized; CSPC OUYI PHARMACEUTICAL CO., LTD.
2026/01/06New drug · Class 1 SYH2082注射液 · No verified English nameCXHL2600018 Beijing Kang Chuang Lian Biopharmaceutical Technology Research Co., Ltd. romanized; CSPC OUYI PHARMACEUTICAL CO., LTD.
2026/01/06New drug · Class 1 NTQ6179片 · No verified English nameCXHL2600015 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.; Zhongguo Yao Ke University romanized
2026/01/06New drug · Class 1 NTQ6179片 · No verified English nameCXHL2600014 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.; Zhongguo Yao Ke University romanized
2026/01/06New drug · Class 1 NTQ6179片 · No verified English nameCXHL2600013 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.; Zhongguo Yao Ke University romanized
2026/01/06New drug · Class 2.3 H008AMX片 · No verified English nameCXHL2600012 Jiangsu Ke Fei Ping Pharmaceuticals Co., Ltd. romanized
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.

103 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.