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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 477 drug applications between 14 August 2026 and 20 August 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 71, covering 54 drug names.

2026/08/14 – 2026/08/20

Period
2026/08/14 to 2026/08/20, 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
477
Drugs with new generic filings (by drug name, de-duplicated)
54
Accepted this week, now under review
241

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

477filings, 71 of them generic

By application type

Application typeFilings
Supplement283
Generic71
New drug70
Import43
Unspecified5
Import re-registration5

By drug type

Drug typeFilings
Chemical drug225
TCM165
Therapeutic biologic79
Prophylactic biologic6
Biologic2

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

54 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

274 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized1530
2Shanghai Min Wei Bio Technology Co., Ltd. romanized1410
3Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized1030
4Eli Lilly and Company930
5Jilin Dao Jun Pharma Co., Ltd. romanized880
6Novo Nordisk A/S820
7Yi Chang Ren Fu Pharma Co., Ltd. romanized733
8F. Hoffmann-La Roche Ltd720
9Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized660
10Tai Ji Group Sichuan Mian Yang Pharmaceutical Co., Ltd. romanized640

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

128 this week

AcceptedDrugApplicants
2026/08/20Import · Class 1 Ixoberogene Soroparvovec 注射液 · No verified English nameJXSL2600217 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/08/20Generic · Class 3 Vincriscristine Sulfate InjectionCYHS2602076 Shenzhen Wan Le Pharma Co., Ltd. romanized
2026/08/20Generic · Class 3 米诺地尔泡沫剂 · No verified English nameCYHS2602075 Jewim Pharmaceutical (Shandong) Co., Ltd.
2026/08/20Generic · Class 3 Azilsartan TabletsCYHS2602071 Zhejiang Nord Pharmaceutical Co., Ltd
2026/08/20Generic · Class 3 磷酸二氢钠磷酸氢二钠颗粒 · No verified English nameCYHS2602070 Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2026/08/20Generic · Class 3 盐酸卡替洛尔滴眼液 · No verified English nameCYHS2602069 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2026/08/20Generic · Class 3 Pirfenidone TabletsCYHS2602065 Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized
2026/08/20New drug · Class 1 LP-003注射液 · No verified English nameCXSS2600130 Tian Chen Biopharmaceuticals (Suzhou) Co., Ltd. romanized; Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/08/20New drug · Class 1 重组抗CD19m-CD3抗体注射液 · No verified English nameCXSL2600889 Tian Mai Yuan He Biopharmaceuticals (Changchun) Co., Ltd. romanized
2026/08/20New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2600888 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/08/20New drug · Class 2.2 瑞拉芙普α注射液 · No verified English nameCXSL2600887 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/08/20New drug · Class 1 RGL-208注射液 · No verified English nameCXSL2600886 Shanghai Rui Hong Di Pharmaceuticals Co., Ltd. romanized; Guangzhou Rui Ling Pharmaceuticals Co., Ltd. romanized
2026/08/20New drug · Class 1 SJ018注射液 · No verified English nameCXSL2600885 Shen Ji Bio (Yi Xing) Co., Ltd. romanized
2026/08/20New drug · Class 1 SHR-4610注射液 · No verified English nameCXSL2600884 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/08/20New drug · Class 1 注射用RGL-232 · No verified English nameCXSL2600883 Shanghai Rui Hong Di Pharmaceuticals Co., Ltd. romanized; Guangzhou Rui Ling Pharmaceuticals Co., Ltd. romanized
2026/08/20New drug · Class 1 RLX-2508注射液 · No verified English nameCXSL2600882 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized; Suzhou Tuo Jie Pharmaceuticals Co., Ltd. romanized
2026/08/20New drug · Class 1 IBI3038 · No verified English nameCXSL2600881 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/08/20New drug · Class 1 HRS-4642注射液 · No verified English nameCXHL2601032 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/08/20New drug · Class 1 HRS-7172片 · No verified English nameCXHL2601031 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/08/20New drug · Class 1 HRS-7172片 · No verified English nameCXHL2601030 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/08/20New drug · Class 1 HRS-7172片 · No verified English nameCXHL2601029 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/08/20New drug · Class 1 HRS-7172片 · No verified English nameCXHL2601028 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/08/20New drug · Class 1 HRS-2329片 · No verified English nameCXHL2601027 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/08/20New drug · Class 1 HRS-2329片 · No verified English nameCXHL2601026 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/08/20New drug · Class 1 HRS-2329片 · No verified English nameCXHL2601025 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/08/20New drug · Class 1 HRS-2329片 · No verified English nameCXHL2601024 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/08/20New drug · Class 2.2 曲前列尼尔二乙醇胺吸入粉雾剂 · No verified English nameCXHL2601023 Shanghai Shang Yao Rui Er Medicines Co., Ltd. romanized; Shanghai Xin Huang He Pharmaceutical Co., Ltd. romanized
2026/08/20New drug · Class 1 普那布林注射用浓溶液 · No verified English nameCXHL2601022 Da Lian Wan Chun Bu Lin Pharmaceuticals Co., Ltd. romanized
2026/08/19Import · Class 3.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600075 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2026/08/19Import · Class 3.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600074 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd

98 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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