YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 362 drug applications between 21 March 2026 and 27 March 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 45, covering 38 drug names.

2026/03/21 – 2026/03/27

Period
2026/03/21 to 2026/03/27, 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
362
Drugs with new generic filings (by drug name, de-duplicated)
38
Accepted this week, now under review
83

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

362filings, 45 of them generic

By application type

Application typeFilings
Supplement231
New drug54
Generic45
Import14
Import re-registration10
Unspecified8

By drug type

Drug typeFilings
Chemical drug193
TCM143
Therapeutic biologic23
Biologic2
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

38 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Oxycodone Hydrochloride and Naloxone Hydrochloride Prolonged-release Tablets313
2Adapalene And Benzoyl Peroxide Gel2230
3Tacrolimus Sustained-release Capsules216
4培美曲塞二钠注射液 · No verified English name212
5头孢地尼颗粒 · No verified English name213
6Baricitinib Tablets2132
7Ethyl Iosapentate Capsules1127
8Pemafibrate Tablets1123
9Crizotinib Capsules117
10Lidocaine and Prilocaine Cream1124

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

212 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Dong E E Jiao Co., Ltd. romanized11100
2Yi Chun Kang Er Xin Pharma Co., Ltd. romanized11100
3Nei Menggu Ku Lun Meng Yao Co., Ltd. romanized880
4Shaanxi Pan Long Pharma Group Co., Ltd. romanized880
5HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.710
6Jilin Ao Dong Yan Bian Pharma Co., Ltd. romanized660
7Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized610
8Takeda Development Center Americas Inc.510
9Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized440
10Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized420

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

79 this week

AcceptedDrugApplicants
2026/03/27Import · Class 2.2 阿伏利尤单抗注射液 · No verified English nameJXSL2600086 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2026/03/27Import · Class 1 贝普若韦生注射液 · No verified English nameJXHS2600033 GlaxoSmithKline Trading Services Limited; GLAXO OPERATIONS UK LTD TRADING AS GLAXO WELLCOME OPERATIONS; GlaxoSmithKline (China) Investment Company Limited
2026/03/27Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2600094 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/03/27Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2600093 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/03/27Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2600092 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/03/27Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2600091 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/03/27Generic · Class 3 Loxoprofen Sodium Oral SolutionCYHS2600731 Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized
2026/03/27Generic · Class 3 Buspirone Hydrochloride TabletsCYHS2600729 Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized
2026/03/27New drug · Class 1 9MW5211注射液 · No verified English nameCXSL2600352 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2026/03/27New drug · Class 1 RGT-490片 · No verified English nameCXHL2600387 Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized
2026/03/27New drug · Class 1 RGT-490片 · No verified English nameCXHL2600386 Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized
2026/03/27New drug · Class 1 TJ0113胶囊 · No verified English nameCXHL2600383 Hangzhou Tian Ji Ji Shi Bio Technology Co., Ltd. romanized
2026/03/27New drug · Class 1 INV-6452片 · No verified English nameCXHL2600382 Guangdong Sheng Innovation Yao Zhuan Hua Yi Xue Research Institute Co., Ltd. romanized; Shenzhen Shi Yuan Li Sheng Ming Ke Xue Co., Ltd. romanized; Fo Shan Shi Yuan Li Bio Technology Co., Ltd. romanized; Shanghai Ju Yuan Bio Technology Co., Ltd. romanized
2026/03/27New drug · Class 1 INV-6452片 · No verified English nameCXHL2600381 Guangdong Sheng Innovation Yao Zhuan Hua Yi Xue Research Institute Co., Ltd. romanized; Shenzhen Shi Yuan Li Sheng Ming Ke Xue Co., Ltd. romanized; Fo Shan Shi Yuan Li Bio Technology Co., Ltd. romanized; Shanghai Ju Yuan Bio Technology Co., Ltd. romanized
2026/03/27New drug · Class 1 拉尼兰诺片 · No verified English nameCXHL2600380 Zheng Da Tian Qing (Guangzhou) Pharmaceuticals Co., Ltd. romanized
2026/03/26Generic · Class 3 碘化钾片 · No verified English nameCYHS2600721 Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.
2026/03/26Generic · Class 3 维生素K?注射液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2600717 Beijing Foyou Pharma CO.,LTD; Jilin Zhen Ao Pharmaceutical Co., Ltd. romanized
2026/03/26New drug · Class 1 QLS2311注射液 · No verified English nameCXSL2600353 Qilu Pharmaceutical Co., Ltd.
2026/03/26New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2600351 An Ming Kang Yuan Pharmaceutical (Jilin) Co., Ltd. romanized; An Kang Yuan Bio Technology (Jilin) Co., Ltd. romanized
2026/03/26New drug · Class 1 注射用SKB571 · No verified English nameCXSL2600350 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2026/03/26New drug · Class 1 ATG-201注射液 · No verified English nameCXSL2600349 De Qi (Hangzhou) Bio Co., Ltd. romanized
2026/03/26New drug · Class 1 BY101921片 · No verified English nameCXHL2600379 Kang Bai Da (Sichuan) Biopharmaceuticals Technology Co., Ltd. romanized
2026/03/26New drug · Class 1 BY101921片 · No verified English nameCXHL2600378 Kang Bai Da (Sichuan) Biopharmaceuticals Technology Co., Ltd. romanized
2026/03/26New drug · Class 1 APH03571片 · No verified English nameCXHL2600374 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2026/03/26New drug · Class 1 APH03571片 · No verified English nameCXHL2600373 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2026/03/26New drug · Class 1 VCT220片 · No verified English nameCXHL2600372 Chengdu Wen Tai Pharmaceuticals Technology Co., Ltd. romanized
2026/03/26New drug · Class 1 VCT220片 · No verified English nameCXHL2600371 Chengdu Wen Tai Pharmaceuticals Technology Co., Ltd. romanized
2026/03/26New drug · Class 1 VCT220片 · No verified English nameCXHL2600370 Chengdu Wen Tai Pharmaceuticals Technology Co., Ltd. romanized
2026/03/26New drug · Class 1 CH3127片 · No verified English nameCXHL2600369 Suzhou Chun Hai Biopharmaceuticals Co., Ltd. romanized
2026/03/26New drug · Class 1 CH3127片 · No verified English nameCXHL2600368 Suzhou Chun Hai Biopharmaceuticals Co., Ltd. romanized

49 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.