YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 344 drug applications between 18 May 2026 and 24 May 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 33, covering 25 drug names.

2026/05/18 – 2026/05/24

Period
2026/05/18 to 2026/05/24, 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
344
Drugs with new generic filings (by drug name, de-duplicated)
25
Accepted this week, now under review
51

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

344filings, 33 of them generic

By application type

Application typeFilings
Supplement207
New drug79
Generic33
Unspecified10
Import re-registration8
Import7

By drug type

Drug typeFilings
TCM151
Chemical drug131
Therapeutic biologic59
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

25 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

218 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Xian Da Tang Pharmaceutical Group Co., Ltd. romanized10100
2Ha Yao Group Bio Gong Cheng Co., Ltd. romanized1050
3Tong Hua Jin Ma Pharma Group Co., Ltd. romanized870
4Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized710
5Shanxi Guang Yu Yuan Guo Yao Co., Ltd. romanized660
6Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized630
7Hunan De Kang Pharmaceutical Co., Ltd. romanized550
8EUROAPI Germany GmbH440
9Hubei Dong Xin Pharma Co., Ltd. romanized440
10Gansu Tian Shui Qi Huang Pharma Co., Ltd. romanized440

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

94 this week

AcceptedDrugApplicants
2026/05/22Import · Class 1 DDY391片 · No verified English nameJXHL2600182 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/05/22Import · Class 1 DDY391片 · No verified English nameJXHL2600181 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/05/22Import · Class 1 BMS-986458片 · No verified English nameJXHL2600180 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2026/05/22Import · Class 1 BMS-986458片 · No verified English nameJXHL2600179 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2026/05/22New drug · Class 1.1 黄氏止咳润喉散 · No verified English nameCXZL2600048 Huang Shi Hou Kang Zhong Pharmaceuticals Co., Ltd. romanized
2026/05/22New drug · Class 1 注射用BL-B01D1(皮下注射) · No verified English nameCXSL2600565 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2026/05/22New drug · Class 1 HH160注射液 · No verified English nameCXSL2600564 Hua Hui An Jian (Beijing) Bio Technology Co., Ltd. romanized
2026/05/22New drug · Class 1 GEB-101 · No verified English nameCXSL2600563 Beijing Yin Zheng Ji Yin Technology Co., Ltd. romanized
2026/05/22New drug · Class 1 注射用3SC009 · No verified English nameCXSL2600562 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2026/05/22New drug · Class 1 QX027N 注射液 · No verified English nameCXSL2600561 Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized
2026/05/22New drug · Class 1 QX027N 注射液 · No verified English nameCXSL2600560 Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized
2026/05/22New drug · Class 1 GenSci144片 · No verified English nameCXHL2600617 Changchun Jin Sai Pharma Co., Ltd. romanized
2026/05/22New drug · Class 1 GenSci144片 · No verified English nameCXHL2600616 Changchun Jin Sai Pharma Co., Ltd. romanized
2026/05/22New drug · Class 1 BIOS0635-048片 · No verified English nameCXHL2600615 Hangzhou Bai Cheng Pharmaceuticals Technology Co., Ltd. romanized
2026/05/22New drug · Class 1 BIOS0635-048片 · No verified English nameCXHL2600614 Hangzhou Bai Cheng Pharmaceuticals Technology Co., Ltd. romanized
2026/05/22New drug · Class 1 BIOS0635-048片 · No verified English nameCXHL2600613 Hangzhou Bai Cheng Pharmaceuticals Technology Co., Ltd. romanized
2026/05/21Import · Class 1 Belantamab (GSK2857914) 注射液 · No verified English nameJXSL2600119 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Company Limited
2026/05/21Import · Class 1 Telisotuzumab Adizutecan 注射用粉末 · No verified English nameJXSL2600118 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2026/05/21Import · Class 2.2 Nemolizumab注射液 · No verified English nameJXSL2600117 Galderma SA; Q-Med International Trading (Shanghai) Co. Ltd
2026/05/21New drug · Class 1.1 归柴止痛颗粒 · No verified English nameCXZL2600047 Shenzhen Shi Shuang Bai Kang Pharmaceuticals Technology Co., Ltd. romanized
2026/05/21New drug · Class 1.1 芪箭颗粒 · No verified English nameCXZL2600046 Kang Chen Pharma (Nei Menggu) Co., Ltd. romanized
2026/05/21New drug · Class 1 RY_SW01细胞注射液 · No verified English nameCXSS2600086 Jiangsu Rui Yuan Bio Technology Co., Ltd. romanized
2026/05/21New drug · Class 1 注射用SKB565 · No verified English nameCXSL2600559 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2026/05/21New drug · Class 1 IPM514注射液 · No verified English nameCXSL2600558 Beijing Zhen Zhi Yi Xue Technology Co., Ltd. romanized
2026/05/21New drug · Class 1 SHR-7012注射液 · No verified English nameCXSL2600557 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/05/21New drug · Class 1 IF001注射液 · No verified English nameCXSL2600556 Yin Fan (Jinan) Biopharmaceuticals Technology Co., Ltd. romanized
2026/05/21New drug · Class 2.2 BN025305H · No verified English nameCXHL2600612 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2026/05/21New drug · Class 2.2 BN025305H · No verified English nameCXHL2600611 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2026/05/21New drug · Class 1 YKYY033注射液 · No verified English nameCXHL2600610 Beijing Yue Kang Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Tian Long Pharma Co., Ltd. romanized
2026/05/21New drug · Class 2.1; 2.4 ICF001吸入粉雾剂 · No verified English nameCXHL2600609 Zhang Feng Su Yue Pharma (Guangzhou) Co., Ltd. romanized; Zhang Feng Pharma Co., Ltd. romanized

64 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.