YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 351 drug applications between 22 October 2026 and 28 October 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 58, covering 45 drug names.

2026/10/22 – 2026/10/28

Period
2026/10/22 to 2026/10/28, 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
351
Drugs with new generic filings (by drug name, de-duplicated)
45
Accepted this week, now under review
335

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

351filings, 58 of them generic

By application type

Application typeFilings
Supplement209
Generic58
New drug46
Import28
Import re-registration6
Unspecified4

By drug type

Drug typeFilings
Chemical drug159
TCM107
Therapeutic biologic73
Biologic6
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

45 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ruxolitinib Phosphate Tablets4227
2Oseltamivir Phosphate Capsules3139
3Suvorexant Tablets313
4复方电解质维持液 · No verified English name212
5Dotinurad Tablets2155
6Sodium Hyaluronate Eye Drops2130
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
9Dalteparin Sodium Injection212
10Upadacitinib Sustained-release Tablets1143

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

240 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Tai Ji Group Chongqing Fu Ling Pharmaceutical Factory Co., Ltd. romanized730
2Merck Europe B.V.530
3AstraZeneca AB520
4Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized510
5Bard Pharmaceuticals Limited440
6Guangxi Wan Tong Pharmaceutical Co., Ltd. romanized440
7Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized440
8Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized430
9Topfond Pharmaceutical Co., Ltd.432
10Novo Nordisk A/S420

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
288
Left the under-review list this week
589

Of these, NMPA published approval-document delivery for 242 (including 229 supplemental applications, not counted as new marketing approvals) and notification delivery for 11; the outcome of the other 336 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
1Eli Lilly and Company144
2Shanghai Min Wei Bio Technology Co., Ltd. romanized141
3F. Hoffmann-La Roche Ltd133
4AstraZeneca AB115
5Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized93
6Shaanxi Dong Tai Pharmaceutical Co., Ltd. romanized87
7Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized85
8Novo Nordisk A/S73
9Novartis Pharma AG65
10Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized62

Most filings entering review, by company

Most filings entering review, by company
#Company (first applicant)FilingsDrugs
1Tai Ji Group Chongqing Fu Ling Pharmaceutical Factory Co., Ltd. romanized73
2Merck Europe B.V.53
3Bard Pharmaceuticals Limited44
4Guangxi Wan Tong Pharmaceutical Co., Ltd. romanized44
5Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized44
6Topfond Pharmaceutical Co., Ltd.43
7Novo Nordisk A/S42
8Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized33
9Henan Run Hong Ben Cao Pharmaceutical Co., Ltd. romanized33
10Guangdong Ke Hong Pharma Co., Ltd. romanized32

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

80 this week

AcceptedDrugApplicants
2026/10/28Import · Class 1 ABBV-706注射用冻干粉 · No verified English nameJXSL2600289 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2026/10/28Import · Class 1 AZD0486 · No verified English nameJXSL2600288 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/10/28Import · Class 1 AZD0486 · No verified English nameJXSL2600287 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/10/28Import · Class 1 AZD4512 · No verified English nameJXSL2600286 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/10/28Generic · Class 3 复方电解质维持液 · No verified English nameCYHS2602639 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized
2026/10/28Generic · Class 3 复方电解质维持液 · No verified English nameCYHS2602638 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized
2026/10/28New drug · Class 2.3 欣力康颗粒 · No verified English nameCXZL2600110 Guiyang Xin Tian Pharma Co., Ltd. romanized
2026/10/28New drug · Class 2.2 注射用瑞康曲妥珠单抗 · No verified English nameCXSS2600174 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Name not romanized
2026/10/28New drug · Class 1 注射用GFS784 · No verified English nameCXSL2601185 Jin Fang Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/10/28New drug · Class 1 CG001注射液 · No verified English nameCXSL2601184 Shanghai Kang Jing Biopharmaceuticals Technology Co., Ltd. romanized
2026/10/28New drug · Class 1 CG001注射液 · No verified English nameCXSL2601183 Shanghai Kang Jing Biopharmaceuticals Technology Co., Ltd. romanized
2026/10/28New drug · Class 1.2 Argo-3004 · No verified English nameCXSL2601182 A Ge Na Biopharmaceutical Co., Ltd. romanized
2026/10/28New drug · Class 1 SSS68注射液 · No verified English nameCXSL2601181 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2026/10/28New drug · Class 1 注射用SKB315 · No verified English nameCXSL2601180 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2026/10/28New drug · Class 1 SKB118注射液 · No verified English nameCXSL2601179 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2026/10/28New drug · Class 1 JZ-603鼻用粉剂 · No verified English nameCXSL2601178 Jiang Zhi Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/10/28New drug · Class 1 JZ-603鼻用粉剂 · No verified English nameCXSL2601177 Jiang Zhi Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/10/28New drug · Class 1 注射用ZG006 · No verified English nameCXSL2601176 Name not romanized
2026/10/28New drug · Class 1 NRT6003注射液 · No verified English nameCXHL2601324 Chengdu Niu Rui Te Medical Technology Co., Ltd. romanized
2026/10/28New drug · Class 2.2 BSD2502 · No verified English nameCXHL2601323 Jiangsu Bai Ao Xin Kang Pharmaceuticals Technology Co., Ltd. romanized
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

50 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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