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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 481 drug applications between 16 July 2026 and 22 July 2026 (data as of 14 November 2026 06:00). Of these, generic applications numbered 74, covering 48 drug names.

2026/07/16 – 2026/07/22

Period
2026/07/16 to 2026/07/22, 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
481
Drugs with new generic filings (by drug name, de-duplicated)
48
Accepted this week, now under review
161

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

481filings, 74 of them generic

By application type

Application typeFilings
Supplement299
New drug75
Generic74
Import25
Unspecified4
Import re-registration4

By drug type

Drug typeFilings
Chemical drug227
TCM155
Therapeutic biologic86
Prophylactic biologic10
Biologic3

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

#DrugNew generic filingsFiling companiesUnder review, all years
1Dotinurad Tablets5255
2Baricitinib Tablets4232
3Adapalene Gel3330
4Brivaracetam Tablets3119
5Emedastine Difumarate Eye Drops229
6布美他尼片 · No verified English name228
7Bromocriptine Mesilate Tablets225
8Polyvinyl Alcohol Eye Drops2224
9Buprenorphine Transdermal Patches216
10Gatifloxacin Eye Drops213

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

280 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S1640
2Jilin Ji Er Ji Pharma Co., Ltd. romanized10100
3Jiangxi Jiu Lian Shan Pharma Co., Ltd. romanized1090
4Qinghai Di Ma Er Zang Yao Pharma Co., Ltd. romanized770
5Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized720
6Merck Sharp & Dohme LLC630
7Fresenius Kabi Austria GmbH610
8Shanxi Hua Kang Pharma Co., Ltd. romanized540
9Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized520
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

121 this week

AcceptedDrugApplicants
2026/07/22Import · Class 1 迪纳西米单抗注射液 · No verified English nameJXSS2600068 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Lt d
2026/07/22Import · Class 1 迪纳西米单抗注射液 · No verified English nameJXSS2600067 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Lt d
2026/07/22Import · Class 1 迪纳西米单抗注射液 · No verified English nameJXSS2600066 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Lt d
2026/07/22Import · Class 1 迪纳西米单抗注射液 · No verified English nameJXSS2600065 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Lt d
2026/07/22Import · Class 1 迪纳西米单抗注射液 · No verified English nameJXSS2600064 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Lt d
2026/07/22Import · Class 1 NN2802 · No verified English nameJXSL2600174 NOVELTY NOBILITY Inc.; Hangzhou Tigermed Consulting Co. Ltd.
2026/07/22Import · Class 1 MK-1084片 · No verified English nameJXHL2600284 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2026/07/22Import · Class 1 MK-1084片 · No verified English nameJXHL2600283 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2026/07/22Generic · Class 3 Colistimethate Sodium for InjectionCYHS2601762 Chengdu Ya Tu Bio Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2026/07/22Generic · Class 3 Ferrous Succinate TabletsCYHS2601757 Chongqing Xi Er An Pharma Co., Ltd. romanized; Chongqing Guo Tai Kang Ning Pharmaceutical Co., Ltd. romanized
2026/07/22New drug · Class 1 注射用BL-M12D1 · No verified English nameCXSL2600763 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2026/07/22New drug · Class 1 SYS6055注射液 · No verified English nameCXSL2600762 Beijing Kang Chuang Lian Biopharmaceutical Technology Research Co., Ltd. romanized
2026/07/22New drug · Class 1 GZC8072片 · No verified English nameCXSL2600761 Gan Li Pharma Shandong Co., Ltd. romanized
2026/07/22New drug · Class 1 GZC8072片 · No verified English nameCXSL2600760 Gan Li Pharma Shandong Co., Ltd. romanized
2026/07/22New drug · Class 1 GZC8072片 · No verified English nameCXSL2600759 Gan Li Pharma Shandong Co., Ltd. romanized
2026/07/22New drug · Class 1 GZC8072片 · No verified English nameCXSL2600758 Gan Li Pharma Shandong Co., Ltd. romanized
2026/07/22New drug · Class 1 BCP601胰岛细胞注射液 · No verified English nameCXSL2600757 Bei Kang Yi Xue Technology Co., Ltd. romanized; Sheng Tai Ying Nuo (Jia Xing) Medical Technology Co., Ltd. romanized
2026/07/22New drug · Class 1 JNJ-95597528注射液 · No verified English nameCXSL2600756 Qiang Sheng (Zhongguo) Investment Co., Ltd. romanized
2026/07/22New drug · Class 1.4 重组呼吸道合胞病毒疫苗(CHO细胞) · No verified English nameCXSL2600755 Beijing Lv Zhu Bio Technology Co., Ltd. romanized; Lv Zhu Biopharmaceutical (Zhuhai Shi) Co., Ltd. romanized
2026/07/22New drug · Class 1 注射用重组人赛普辛希 · No verified English nameCXSL2600754 Changzhou Zhang Ji Bio Technology Kai Fa Co., Ltd. romanized
2026/07/22New drug · Class 1 CMS-X016注射液 · No verified English nameCXSL2600747 Shenzhen Shi Kang Zhe Wei Sheng Pharmaceuticals Development Co., Ltd. romanized
2026/07/22New drug · Class 1 QX-4533片 · No verified English nameCXHL2600894 Qu Xin Bio Technology (Shanghai) Co., Ltd. romanized
2026/07/22New drug · Class 1 QX-4533片 · No verified English nameCXHL2600893 Qu Xin Bio Technology (Shanghai) Co., Ltd. romanized
2026/07/22New drug · Class 1 QX-4533片 · No verified English nameCXHL2600892 Qu Xin Bio Technology (Shanghai) Co., Ltd. romanized
2026/07/22New drug · Class 2.4 奥布替尼片 · No verified English nameCXHL2600891 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2026/07/21Import · Class 1 PF-08634404 · No verified English nameJXSL2600173 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/21Import · Class 1 MK-4716片 · No verified English nameJXHL2600282 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2026/07/21Import · Class 1 MK-4716片 · No verified English nameJXHL2600281 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2026/07/21Import · Class 1 MK-4716片 · No verified English nameJXHL2600280 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2026/07/21Generic · Class 3 布美他尼片 · No verified English nameCYHS2601746 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized

91 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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