YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 499 drug applications between 21 July 2026 and 27 July 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 62, covering 48 drug names.

2026/07/21 – 2026/07/27

Period
2026/07/21 to 2026/07/27, 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
499
Drugs with new generic filings (by drug name, de-duplicated)
48
Accepted this week, now under review
160

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

499filings, 62 of them generic

By application type

Application typeFilings
Supplement309
New drug79
Generic62
Import29
Unspecified17
Import re-registration3

By drug type

Drug typeFilings
Chemical drug243
TCM165
Therapeutic biologic77
Biologic8
Prophylactic biologic6

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

48 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

295 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S2160
2Jiangxi Jiu Lian Shan Pharma Co., Ltd. romanized1090
3Merck Sharp & Dohme LLC840
4Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized720
5Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized630
6Changchun Jin Sai Pharma Co., Ltd. romanized630
7Shaanxi Dong Tai Pharmaceutical Co., Ltd. romanized550
8Li Shi Zhen Pharmaceuticals Group Co., Ltd. romanized540
9Pfizer Inc.520
10Bao Tou Zhong Yao Co., Ltd. romanized520

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

115 this week

AcceptedDrugApplicants
2026/07/27Import · Class 1 PF-08653944注射液 · No verified English nameJXHL2600291 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/27Import · Class 1 PF-08653944注射液 · No verified English nameJXHL2600290 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/27Import · Class 1 PF-08653944注射液 · No verified English nameJXHL2600289 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/27Import · Class 1 PF-08653944注射液 · No verified English nameJXHL2600288 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/27Import · Class 1 RO7568282胶囊 · No verified English nameJXHL2600287 F. Hoffmann-La Roche Ltd; Roche R&D Center (China) Ltd.
2026/07/27Import · Class 1 RO7568282胶囊 · No verified English nameJXHL2600286 F. Hoffmann-La Roche Ltd; Roche R&D Center (China) Ltd.
2026/07/27Generic · Class 3 Sodium Lactate Ringer's Irrigation SolutionCYHS2601790 Hunan Kang Yuan Pharmaceutical Co., Ltd. romanized
2026/07/27Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHS2601788 Nanjing Hua Gai Pharmaceutical Co., Ltd. romanized
2026/07/27Generic · Class 3 Bifonazole SolutionCYHS2601784 Suzhou Gao Mai Pharma Co., Ltd. romanized; Tang Shan Hong Xing Pharma Co., Ltd. romanized
2026/07/27New drug · Class 1.1 TDX105颗粒 · No verified English nameCXZL2600066 Tian Shi Li Pharmaceuticals Group Co., Ltd. romanized
2026/07/27New drug · Class 2.4 注射用重组A型肉毒毒素(Sf9细胞,150 kD天然氨基酸序列) · No verified English nameCXSL2600779 Suzhou Ruo Yi Bio Technology Co., Ltd. romanized
2026/07/27New drug · Class 1 Cizutamig注射液(皮下注射) · No verified English nameCXSL2600778 Shanghai Tan Di Biopharmaceuticals Technology Co., Ltd. romanized
2026/07/27New drug · Class 1 TGI-10注射液 · No verified English nameCXSL2600777 Hefei Tian Gang Mian Yi Drug Co., Ltd. romanized
2026/07/27New drug · Class 1 NouvSight001 · No verified English nameCXSL2600776 Rui Jian Yi Lian Pharmaceuticals Technology (Chengdu) Co., Ltd. romanized; Wuhan Rui Jian Pharmaceuticals Technology Co., Ltd. romanized
2026/07/27New drug · Class 1 GenSci155注射液 · No verified English nameCXSL2600775 Changchun Jin Sai Pharma Co., Ltd. romanized
2026/07/27New drug · Class 1 GenSci155注射液 · No verified English nameCXSL2600774 Changchun Jin Sai Pharma Co., Ltd. romanized
2026/07/27New drug · Class 1 LDR1259注射液 · No verified English nameCXHL2600918 Chengdu Xian Yan Bio Technology Co., Ltd. romanized
2026/07/27New drug · Class 1 IMP1734片 · No verified English nameCXHL2600917 Shanghai Ying Pai Pharma Co., Ltd. romanized
2026/07/27New drug · Class 1 IMP1734片 · No verified English nameCXHL2600916 Shanghai Ying Pai Pharma Co., Ltd. romanized
2026/07/27New drug · Class 1 QX-6胶囊 · No verified English nameCXHL2600915 Jiangxi Pu Zheng Pharmaceutical Co., Ltd. romanized; Zhongguo Yi Xue Ke College Yao Yong Zhi Wu Research Institute romanized
2026/07/27New drug · Class 1 QX-6胶囊 · No verified English nameCXHL2600914 Jiangxi Pu Zheng Pharmaceutical Co., Ltd. romanized; Zhongguo Yi Xue Ke College Yao Yong Zhi Wu Research Institute romanized
2026/07/27New drug · Class 1 737NL01注射液 · No verified English nameCXHL2600913 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2026/07/27New drug · Class 1 737NL01注射液 · No verified English nameCXHL2600912 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2026/07/27New drug · Class 1 HSK56630片 · No verified English nameCXHL2600911 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2026/07/27New drug · Class 1 HSK56630片 · No verified English nameCXHL2600910 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2026/07/27New drug · Class 2.4 复方RY2乳膏 · No verified English nameCXHL2600909 Nanjing Rui Ying Run Ze Biopharmaceuticals Technology Co., Ltd. romanized; Zhongguo Yao Ke University romanized; Shandong Run Ze Zi Hua Pharma Co., Ltd. romanized
2026/07/27New drug · Class 2.4 复方RY2乳膏 · No verified English nameCXHL2600908 Nanjing Rui Ying Run Ze Biopharmaceuticals Technology Co., Ltd. romanized; Zhongguo Yao Ke University romanized; Shandong Run Ze Zi Hua Pharma Co., Ltd. romanized
2026/07/27New drug · Class 2.4 复方RY2乳膏 · No verified English nameCXHL2600907 Nanjing Rui Ying Run Ze Biopharmaceuticals Technology Co., Ltd. romanized; Zhongguo Yao Ke University romanized; Shandong Run Ze Zi Hua Pharma Co., Ltd. romanized
2026/07/24Import · Class 2.2 MK-3475A注射液 · No verified English nameJXSL2600177 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2026/07/24Import · Class 2.2 MK-3475A注射液 · No verified English nameJXSL2600176 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd

85 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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