YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 452 drug applications between 26 July 2026 and 1 August 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 71, covering 50 drug names.

2026/07/26 – 2026/08/01

Period
2026/07/26 to 2026/08/01, 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
452
Drugs with new generic filings (by drug name, de-duplicated)
50
Accepted this week, now under review
157

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

452filings, 71 of them generic

By application type

Application typeFilings
Supplement240
New drug91
Generic71
Import29
Unspecified14
Import re-registration7

By drug type

Drug typeFilings
Chemical drug253
TCM130
Therapeutic biologic63
Biologic5
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

50 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

275 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1AstraZeneca AB950
2AbbVie Inc.840
3Liaoning Min Kang Pharmaceutical Co., Ltd. romanized620
4Name not romanized610
5Shanghai Kai Bao Xin Yi (Xin Xiang) Pharma Co., Ltd. romanized550
6Heng Tuo Group Guangxi Sheng Kang Pharmaceutical Co., Ltd. romanized550
7Novo Nordisk A/S510
8Takeda Development Center Americas Inc.510
9Qinghai Di Ma Er Zang Yao Pharma Co., Ltd. romanized440
10Chengdu Jiu Zhi Tang Jin Ding Pharma Co., Ltd. romanized430

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

135 this week

AcceptedDrugApplicants
2026/07/31Generic · Class 3 硫酸阿托品滴眼液 · No verified English nameCYHS2601848 Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized
2026/07/31New drug · Class 1.1 复方野菊花颗粒 · No verified English nameCXZL2600068 Zhejiang Zhong Pharmaceuticals University romanized
2026/07/31New drug · Class 1.1 藿连消滞颗粒 · No verified English nameCXZL2600067 He Guang Zhong Yao Technology (Tianjin) Co., Ltd. romanized
2026/07/31New drug · Class 2.4 注射用重组A型肉毒毒素(Sf9细胞,150 kD天然氨基酸序列) · No verified English nameCXSL2600807 Suzhou Ruo Yi Bio Technology Co., Ltd. romanized
2026/07/31New drug · Class 1 注射用3SN001 · No verified English nameCXSL2600806 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2026/07/31New drug · Class 1 SCT810注射液 · No verified English nameCXSL2600805 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2026/07/31New drug · Class 1 镥[177Lu]-BL-ARC001注射液 · No verified English nameCXSL2600804 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2026/07/31New drug · Class 1 注射用HCRB001 · No verified English nameCXSL2600803 Haikou Tie Shu Da Fang Bio Technology Co., Ltd. romanized
2026/07/31New drug · Class 1 SI-B001双特异性抗体注射液 · No verified English nameCXSL2600802 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2026/07/31New drug · Class 1 注射用AMT-676 · No verified English nameCXSL2600801 Pu Zhong Fa Xian Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/07/31New drug · Class 1 注射用DR30206 · No verified English nameCXSL2600800 Zhejiang Dao Er Bio Technology Co., Ltd. romanized
2026/07/31New drug · Class 1 TQB3909片 · No verified English nameCXHS2600113 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD; Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2026/07/31New drug · Class 1 TQB3909片 · No verified English nameCXHS2600112 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD; Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2026/07/31New drug · Class 1 ARTS-980片 · No verified English nameCXHL2600951 An Rui Biopharmaceuticals Technology (Guangzhou) Co., Ltd. romanized
2026/07/31New drug · Class 1 ARTS-980片 · No verified English nameCXHL2600950 An Rui Biopharmaceuticals Technology (Guangzhou) Co., Ltd. romanized
2026/07/31New drug · Class 2.4 SL-0010 · No verified English nameCXHL2600949 Shanghai Ze Zheng Pharmaceuticals Technology Co., Ltd. romanized
2026/07/31New drug · Class 1 BPR-30221616注射液 · No verified English nameCXHL2600948 Chengdu Bei Te Rui Ma Biopharmaceuticals Technology Co., Ltd. romanized
2026/07/31New drug · Class 2.4 SL-0010 · No verified English nameCXHL2600947 Shanghai Ze Zheng Pharmaceuticals Technology Co., Ltd. romanized
2026/07/31New drug · Class 2.4 SL-0010 · No verified English nameCXHL2600946 Shanghai Ze Zheng Pharmaceuticals Technology Co., Ltd. romanized
2026/07/31New drug · Class 1 HRS-8046片 · No verified English nameCXHL2600945 Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/07/31New drug · Class 1 HRS-8046片 · No verified English nameCXHL2600944 Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/07/31New drug · Class 1 注射用 AST-006 · No verified English nameCXHL2600943 Shenzhen Ai Xin Da Wei Pharmaceuticals Technology Co., Ltd. romanized
2026/07/31New drug · Class 1 MI078胶囊 · No verified English nameCXHL2600942 Nanjing Mai Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2026/07/31New drug · Class 1 F1F3软膏 · No verified English nameCXHL2600941 Zhong Ao Biopharmaceuticals Technology (Guangdong) Co., Ltd. romanized
2026/07/31New drug · Class 1 F1F3软膏 · No verified English nameCXHL2600940 Zhong Ao Biopharmaceuticals Technology (Guangdong) Co., Ltd. romanized
2026/07/30Import · Class 1 AZD5335 · No verified English nameJXSL2600179 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/07/30Import · Class 1 ABBV-142注射液/输注液 · No verified English nameJXSL2600178 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2026/07/30Import · Class 2.4 Upadacitinib Sustained-release TabletsJXHL2600308 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2026/07/30Import · Class 1 ABBV-722薄膜衣片 · No verified English nameJXHL2600307 AbbVie Inc.
2026/07/30Import · Class 1 ABBV-722薄膜衣片 · No verified English nameJXHL2600306 AbbVie Inc.

105 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.