YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 493 drug applications between 29 July 2026 and 4 August 2026 (data as of 14 November 2026 06:00). Of these, generic applications numbered 80, covering 58 drug names.

2026/07/29 – 2026/08/04

Period
2026/07/29 to 2026/08/04, 7 days inclusive
Data as of
2026/11/14 06:00
Cached records
94,880 acceptance records, 11,632 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
493
Drugs with new generic filings (by drug name, de-duplicated)
58
Accepted this week, now under review
189

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

493filings, 80 of them generic

By application type

Application typeFilings
Supplement271
New drug86
Generic80
Import36
Unspecified12
Import re-registration8

By drug type

Drug typeFilings
Chemical drug238
TCM174
Therapeutic biologic77
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

58 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1地氯雷他定口服溶液 · No verified English name4226
2Nafamostat Mesilate for Injection3238
3Ixazomib Citrate Capsules317
4Edaravone and Dexborneol Concentrated Solution for Injection2234
5盐酸氮?斯汀鼻喷雾剂 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.227
6Ipratropium Bromide Inhalation Solution212
7Dotinurad Tablets2155
8Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution2123
9注射用托伐普坦磷酸钠 · No verified English name2115
10Loxoprofen Sodium Patches2130

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

278 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Beijing Bao Shu Tang Technology Pharma Co., Ltd. romanized18170
2Eli Lilly and Company1120
3AbbVie Inc.960
4Jiao Zuo Fu Rui Tang Pharmaceutical Co., Ltd. romanized660
5Guangzhou Wang Lao Ji Pharma Co., Ltd. romanized650
6Liaoning Min Kang Pharmaceutical Co., Ltd. romanized620
7Name not romanized610
8Li Zhu Group Li Min Pharmaceutical Factory romanized610
9Shanghai Kai Bao Xin Yi (Xin Xiang) Pharma Co., Ltd. romanized550
10CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD523

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

143 this week

AcceptedDrugApplicants
2026/08/04Import · Class 2.2 注射用维得利珠单抗 · No verified English nameJXSS2600070 Takeda Pharma A/S; Takeda Pharmaceutical Company Ltd.; Takeda (China) International Trading Co. Ltd
2026/08/04Import · Class 2.2 注射用维得利珠单抗 · No verified English nameJXSS2600069 Takeda Pharma A/S; Takeda Pharmaceutical Company Ltd.; Takeda (China) International Trading Co. Ltd
2026/08/04Import · Class 1 RO7568282胶囊 · No verified English nameJXHL2600322 F. Hoffmann-La Roche Ltd; Roche R&D Center (China) Ltd.
2026/08/04Import · Class 1 RO7568282胶囊 · No verified English nameJXHL2600321 F. Hoffmann-La Roche Ltd; Roche R&D Center (China) Ltd.
2026/08/04Import · Class 1 LY900043注射液 · No verified English nameJXHL2600320 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/08/04Import · Class 1 LY900043注射液 · No verified English nameJXHL2600319 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/08/04Import · Class 1 LY900043注射液 · No verified English nameJXHL2600318 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/08/04Import · Class 1 LY900043注射液 · No verified English nameJXHL2600317 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/08/04Import · Class 1 LY900043注射液 · No verified English nameJXHL2600316 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/08/04Import · Class 1 LY900043注射液 · No verified English nameJXHL2600315 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/08/04Import · Class 1 LY900043注射液 · No verified English nameJXHL2600314 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/08/04Generic · Class 3 克霉唑含片 · No verified English nameCYHS2601888 Hai Hong Heng Long (Hainan) Bio Technology Co., Ltd. romanized; Jiangsu Ya Bang Qiang Sheng Pharma Co., Ltd. romanized
2026/08/04Generic · Class 3 Sivelestat Sodium for InjectionCYHS2601887 Chengdu Nuo He Cheng Hong Biopharmaceutical Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2026/08/04Generic · Class 3 Acetylcysteine GranulesCYHS2601886 Jiangxi Ren Qi Pharmaceutical Co., Ltd. romanized
2026/08/04Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601885 Henan Xin Tai Pharma Co., Ltd. romanized
2026/08/04Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601884 Henan Xin Tai Pharma Co., Ltd. romanized
2026/08/04New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600119 Lian Yun Gang Run Zhong Pharmaceutical Co., Ltd. romanized
2026/08/04New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600118 Lian Yun Gang Run Zhong Pharmaceutical Co., Ltd. romanized
2026/08/04New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600117 Lian Yun Gang Run Zhong Pharmaceutical Co., Ltd. romanized
2026/08/04New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600116 Lian Yun Gang Run Zhong Pharmaceutical Co., Ltd. romanized
2026/08/04New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600115 Lian Yun Gang Run Zhong Pharmaceutical Co., Ltd. romanized
2026/08/04New drug · Class 2.2 安尼妥单抗注射液 · No verified English nameCXSS2600114 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized; Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2026/08/04New drug · Class 1 SNA01注射液 · No verified English nameCXSL2600818 Beijing Ke Xing Holding (Group) Co., Ltd. romanized; Zhongguo Ke College Bio Wu Li Research Institute romanized
2026/08/04New drug · Class 1 ZHB123舌下片 · No verified English nameCXSL2600817 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized
2026/08/04New drug · Class 1 ZHB123舌下片 · No verified English nameCXSL2600816 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized
2026/08/04New drug · Class 1 XLS-103注射液 · No verified English nameCXSL2600815 Xiang Xue Sheng Ming Ke Xue Technology (Guangdong) Co., Ltd. romanized
2026/08/04New drug · Class 1 GenSci133注射液 · No verified English nameCXSL2600814 Changchun Jin Sai Pharma Co., Ltd. romanized
2026/08/04New drug · Class 1 IBI3034 · No verified English nameCXSL2600813 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/08/04New drug · Class 1 SYS6062 · No verified English nameCXSL2600812 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2026/08/04New drug · Class 2.2 注射用多西他赛(白蛋白结合型) · No verified English nameCXHS2600114 CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.

113 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.