YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 403 drug applications between 18 October 2026 and 24 October 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 60, covering 48 drug names.

2026/10/18 – 2026/10/24

Period
2026/10/18 to 2026/10/24, 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
403
Drugs with new generic filings (by drug name, de-duplicated)
48
Accepted this week, now under review
375

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

403filings, 60 of them generic

By application type

Application typeFilings
Supplement235
New drug66
Generic60
Import29
Import re-registration8
Unspecified5

By drug type

Drug typeFilings
Chemical drug203
TCM125
Therapeutic biologic68
Biologic5
In vitro diagnostic reagent1
Prophylactic biologic1

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

262 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hunan Dong Jian Pharma Co., Ltd. romanized880
2Eli Lilly and Company710
3Janssen-Cilag International NV640
4AbbVie Inc.530
5Medice Arzneimittel Pütter GmbH & Co. KG510
6Topfond Pharmaceutical Co., Ltd.440
7Guangxi Wan Tong Pharmaceutical Co., Ltd. romanized440
8Shan Tou Shi Shi Dai Pharmaceutical Co., Ltd. romanized440
9Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized440
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
149
Left the under-review list this week
316

Of these, NMPA published approval-document delivery for 161 (including 153 supplemental applications, not counted as new marketing approvals) and notification delivery for 10; the outcome of the other 145 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 Company123
2F. Hoffmann-La Roche Ltd122
3Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized74
4Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized62
5AstraZeneca AB53
6Novo Nordisk A/S51
7Shanghai Kai Bao Xin Yi (Xin Xiang) Pharma Co., Ltd. romanized44
8Novartis Pharma AG43
9Su Zhou Yi Fan Pharma Co., Ltd. romanized43
10Guangzhou Wang Lao Ji Pharma Co., Ltd. romanized43

Most filings entering review, by company

Most filings entering review, by company
#Company (first applicant)FilingsDrugs
1Guangxi Wan Tong Pharmaceutical Co., Ltd. romanized44
2Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized44
3Novo Nordisk A/S42
4Zhejiang Er Ying Medicines Co., Ltd. romanized31
5Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized31
6Zuo Jin Ming Pharmaceutical Co., Ltd. romanized22
7Beijing Mian Yi Fang Zhou Pharmaceuticals Technology Co., Ltd. romanized22
8Hua Run Shuang He Xiang Zhong Pharma (Hunan) Co., Ltd. romanized22
9Jilin Ji Chun Pharmaceutical Co., Ltd. romanized22
10Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized22

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

105 this week

AcceptedDrugApplicants
2026/10/23Import · Class 2.2 萨特利珠单抗注射液 · No verified English nameJXSS2600098 Roche Pharma (Schweiz) AG; Utsunomiya Plant of Chugai Pharma Manufacturing Co. Ltd.; Roche (China) Holding Ltd.
2026/10/23Import · Class 1 AZD0486 · No verified English nameJXSL2600284 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/10/23Import · Class 1 AZD0486 · No verified English nameJXSL2600283 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/10/23Import · Class 1 注射用ABBV-969 · No verified English nameJXSL2600282 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2026/10/23Import · Class 1 579 - 痤疮 mRNA 注射液 · No verified English nameJXSL2600281 Sanofi Vaccines US Inc.; Shenzhen Sanofi Biological Products Co. Ltd.
2026/10/23Import · Class 2.4 甲苯磺酸利特昔替尼胶囊 · No verified English nameJXHS2600132 Pfizer Inc.; Pfizer Manufacturing Deutschland GmbH; Pfizer Investment Co. Ltd.
2026/10/23Import · Class 2.4 甲苯磺酸利特昔替尼胶囊 · No verified English nameJXHS2600131 Pfizer Inc.; Pfizer Manufacturing Deutschland GmbH; Pfizer Investment Co. Ltd.
2026/10/23Generic · Class 3 Betahistine Dihydrochloride TabletsCYHS2602608 Ka Wen Di Xu (Tai Zhou) Pharma Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd.
2026/10/23Generic · Class 3 双氯芬酸依泊胺凝胶贴膏 · No verified English nameCYHL2600121 Hangzhou Duan Ben Pharmaceuticals Technology Co., Ltd. romanized
2026/10/23New drug · Class 1.1 逍遥静音颗粒 · No verified English nameCXZL2600107 Beijing Xin Rui Yuan Pharmaceuticals Technology Co., Ltd. romanized
2026/10/23New drug · Class 2.2 注射用伦康依隆妥单抗 · No verified English nameCXSS2600168 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Name not romanized
2026/10/23New drug · Class 1 泰利奇拜单抗注射液(皮下注射) · No verified English nameCXSS2600167 Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized
2026/10/23New drug · Class 1 IMM040811注射液 · No verified English nameCXSL2601169 Beijing Mian Yi Fang Zhou Pharmaceuticals Technology Co., Ltd. romanized
2026/10/23New drug · Class 1 IMM092注射液 · No verified English nameCXSL2601168 Beijing Mian Yi Fang Zhou Pharmaceuticals Technology Co., Ltd. romanized
2026/10/23New drug · Class 1 KN060注射液 · No verified English nameCXSL2601167 Suzhou Kang Ning Jie Rui Bio Technology Co., Ltd. romanized
2026/10/23New drug · Class 1 注射用HLX403 · No verified English nameCXSL2601166 Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized
2026/10/23New drug · Class 1 TQC3721吸入粉雾剂 · No verified English nameCXHL2601320 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2026/10/23New drug · Class 1 TQC3721吸入粉雾剂 · No verified English nameCXHL2601319 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2026/10/23New drug · Class 1 OV329胶囊 · No verified English nameCXHL2601318 Di Mai Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/10/23New drug · Class 1 OV329胶囊 · No verified English nameCXHL2601317 Di Mai Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/10/22Generic · Class 3 Alendronate Sodium Oral SolutionCYHS2602600 Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2026/10/22Generic · Class 3 艾地骨化醇片 · No verified English nameCYHS2602592 Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized
2026/10/22Generic · Class 3 Calcium Gluconate InjectionCYHS2602590 HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2026/10/22Generic · Class 3 lorazepam injectionCYHL2600120 Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized
2026/10/22New drug · Class 2.5 冻干人用狂犬病疫苗(Vero细胞) · No verified English nameCXSL2601165 Guangzhou Bai Yun Shan Bio Zhi Pin Co., Ltd. romanized
2026/10/22New drug · Class 1 NK010(冻存制剂)细胞注射液 · No verified English nameCXSL2601164 Shanghai En Kai Xi Bao Technology Co., Ltd. romanized
2026/10/22New drug · Class 1 JK06注射液 · No verified English nameCXSL2601163 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2026/10/22New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2601162 Tianjin He Chuang Bio Technology Co., Ltd. romanized
2026/10/22New drug · Class 1 CG-0416片 · No verified English nameCXHL2601316 Shanghai Ke Jun Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Ke Jin Zi Xun Management Co., Ltd. romanized
2026/10/22New drug · Class 1 CG-0416片 · No verified English nameCXHL2601315 Shanghai Ke Jun Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Ke Jin Zi Xun Management Co., Ltd. romanized

75 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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