YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 422 drug applications between 21 October 2026 and 27 October 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 62, covering 47 drug names.

2026/10/21 – 2026/10/27

Period
2026/10/21 to 2026/10/27, 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
422
Drugs with new generic filings (by drug name, de-duplicated)
47
Accepted this week, now under review
400

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

422filings, 62 of them generic

By application type

Application typeFilings
Supplement252
Generic62
New drug56
Import37
Import re-registration10
Unspecified5

By drug type

Drug typeFilings
Chemical drug199
TCM139
Therapeutic biologic74
Biologic6
Prophylactic biologic3
In vitro diagnostic reagent1

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

47 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ruxolitinib Phosphate Tablets4227
2Sodium Hyaluronate Eye Drops3230
3Suvorexant Tablets313
4Acetylcysteine Oral Solution2111
5Dotinurad Tablets2155
6环硅酸锆钠散 · No verified English name2112
7苯磺酸美洛加巴林口崩片 · No verified English name212
8西诺氨酯片 · No verified English name2124
9Dapagliflozin Tablets2184
10Dalteparin Sodium Injection212

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

276 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hunan Dong Jian Pharma Co., Ltd. romanized10100
2Tai Ji Group Chongqing Fu Ling Pharmaceutical Factory Co., Ltd. romanized730
3AbbVie Inc.640
4Merck Europe B.V.530
5Bard Pharmaceuticals Limited440
6Guangxi Wan Tong Pharmaceutical Co., Ltd. romanized440
7Shan Tou Shi Shi Dai Pharmaceutical Co., Ltd. romanized440
8Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized440
9Heilongjiang Bi Fu Jin Bei Yao Pharmaceutical Co., Ltd. romanized440
10Janssen-Cilag International NV430

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

Entered review this week
223
Left the under-review list this week
492

Of these, NMPA published approval-document delivery for 200 (including 187 supplemental applications, not counted as new marketing approvals) and notification delivery for 11; the outcome of the other 281 is to be checked.

Data collected since 2026/10/22: this week counts snapshots from 2026/10/23 only.

Most filings leaving review, by company

Most filings leaving review, by company
#Company (first applicant)FilingsDrugs
1F. Hoffmann-La Roche Ltd133
2Eli Lilly and Company123
3AstraZeneca AB115
4Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized93
5Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized74
6Novo Nordisk A/S73
7Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized62
8Ning Kang Rui Zhu Biopharmaceutical (Zhuhai) Co., Ltd. romanized62
9Shandong Lv Ye Pharmaceutical Co., Ltd. romanized61
10Novartis Pharma AG54

Most filings entering review, by company

Most filings entering review, by company
#Company (first applicant)FilingsDrugs
1Merck Europe B.V.53
2Guangxi Wan Tong Pharmaceutical Co., Ltd. romanized44
3Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized44
4Topfond Pharmaceutical Co., Ltd.43
5Novo Nordisk A/S42
6Guangdong Ke Hong Pharma Co., Ltd. romanized32
7Guangdong Hao Rui En Pharmaceutical Co., Ltd. romanized31
8Zhejiang Er Ying Medicines Co., Ltd. romanized31
9Hubei Min Kang Pharmaceutical Co., Ltd. romanized31
10Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized31

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

99 this week

AcceptedDrugApplicants
2026/10/27Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSS2600099 MSD International Business GmbH; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd.
2026/10/27Import · Class 1 Giredestrant胶囊 · No verified English nameJXHL2600465 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/10/27Import · Class 1 Giredestrant胶囊 · No verified English nameJXHL2600464 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/10/27Generic · Class 3 Bilastine Oral SolutionCYHS2602628 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2026/10/27Generic · Class 3 贝派度酸依折麦布片 · No verified English nameCYHL2600125 Chengdu Nuo He Cheng Hong Biopharmaceutical Co., Ltd. romanized
2026/10/27New drug · Class 2.3 金叶败毒颗粒 · No verified English nameCXZL2600109 Guo Yao Group Zhong Lian Pharma Co., Ltd. romanized
2026/10/27New drug · Class 2.1 特瑞普利单抗注射液(皮下注射) · No verified English nameCXSS2600173 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized
2026/10/27New drug · Class 2.2 注射用芦康沙妥珠单抗 · No verified English nameCXSS2600172 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2026/10/27New drug · Class 2.2 注射用芦康沙妥珠单抗 · No verified English nameCXSS2600171 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2026/10/27New drug · Class 1 注射用LY4052031 · No verified English nameCXSL2601175 Li Lai Suzhou Pharmaceutical Co., Ltd. romanized
2026/10/27New drug · Class 1 KYS2302注射液 · No verified English nameCXSL2601174 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2026/10/27New 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 nameCXSL2601173 Suzhou Ruo Yi Bio Technology Co., Ltd. romanized
2026/10/27New drug · Class 1 RO7840734 · No verified English nameCXHL2601322 Luo Shi (Zhongguo) Investment Co., Ltd. romanized
2026/10/27New drug · Class 1 RO7840734 · No verified English nameCXHL2601321 Luo Shi (Zhongguo) Investment Co., Ltd. romanized
2026/10/26Import · Class 1 ABBV-901注射用粉末 · No verified English nameJXSL2600285 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2026/10/26Import · Class 1 Azenosertib片 · No verified English nameJXHL2600463 K-Group Beta Inc.; Hangzhou Tigermed Consulting Co. Ltd.
2026/10/26Import · Class 1 Azenosertib片 · No verified English nameJXHL2600462 K-Group Beta Inc.; Hangzhou Tigermed Consulting Co. Ltd.
2026/10/26Import · Class 2.4 注射用WCK 5222 · No verified English nameJXHL2600461 Wockhardt Bio AG; Fortrea Pharmaceutical Research and Development (Beijing) Co. Ltd.
2026/10/26Generic · Class 3 亚硒酸钠注射液 · No verified English nameCYHS2602625 Ren He Yi Kang Hui Ze Pharma Hebei Co., Ltd. romanized
2026/10/26Generic · Class 3 苯磺酸美洛加巴林口崩片 · No verified English nameCYHS2602617 Topfond Pharmaceutical Co., Ltd.
2026/10/26Generic · Class 3 苯磺酸美洛加巴林口崩片 · No verified English nameCYHS2602616 Topfond Pharmaceutical Co., Ltd.
2026/10/26Generic · Class 3 Suvorexant TabletsCYHL2600124 Guangdong Hao Rui En Pharmaceutical Co., Ltd. romanized
2026/10/26Generic · Class 3 Suvorexant TabletsCYHL2600123 Guangdong Hao Rui En Pharmaceutical Co., Ltd. romanized
2026/10/26Generic · Class 3 Suvorexant TabletsCYHL2600122 Guangdong Hao Rui En Pharmaceutical Co., Ltd. romanized
2026/10/26New drug · Class 2.3 黄葵胶囊 · No verified English nameCXZL2600108 Su Zhong Pharma Group Co., Ltd. romanized
2026/10/26New drug · Class 2.2 信迪利单抗注射液 · No verified English nameCXSS2600170 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/10/26New drug · Class 1 诺吉仑赛注射液 · No verified English nameCXSS2600169 Shanghai Jun Sai Bio Pharma Co., Ltd. romanized
2026/10/26New drug · Class 1 CM398注射液 · No verified English nameCXSL2601172 Kang Nuo Ya Biopharmaceuticals Technology Co., Ltd. romanized
2026/10/26New drug · Class 1 SPGL008注射液 · No verified English nameCXSL2601171 Shenzhen Sai Bao Er Bio Pharma Co., Ltd. romanized
2026/10/26New drug · Class 1 SSGJ-706注射液 · No verified English nameCXSL2601170 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized

69 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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