YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 513 drug applications between 10 May 2026 and 16 May 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 97, covering 63 drug names.

2026/05/10 – 2026/05/16

Period
2026/05/10 to 2026/05/16, 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
513
Drugs with new generic filings (by drug name, de-duplicated)
63
Accepted this week, now under review
146

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

513filings, 97 of them generic

By application type

Application typeFilings
Supplement285
Generic97
New drug93
Import19
Import re-registration11
Unspecified8

By drug type

Drug typeFilings
Chemical drug270
TCM168
Therapeutic biologic65
Biologic8
Prophylactic 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

63 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

283 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Ha Yao Group Bio Gong Cheng Co., Ltd. romanized26100
2Tai Ji Group Chongqing Tong Jun Ge Pharmaceutical Factory Co., Ltd. romanized14120
3Karuna Therapeutics Inc. a Bristol Myers Squibb Company820
4Pi Ai Sai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized660
5Bao Tou Zhong Yao Co., Ltd. romanized640
6Kyowa Kirin Co. Ltd.610
7Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized610
8Guangxi Yu Lin Pharmaceutical Group Co., Ltd. romanized550
9Henan Bai Nian Kang Xin Pharma Co., Ltd. romanized550
10Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized530

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

144 this week

AcceptedDrugApplicants
2026/05/15Import · Class 1 Galvokimig注射液 · No verified English nameJXSL2600116 UCB Biopharma SRL; UCB Trading (Shanghai) Co. Ltd
2026/05/15New drug · Class 2.3 障眼明片 · No verified English nameCXZL2600045 Guangzhou Bai Yun Shan Zhong Yi Pharma Co., Ltd. romanized
2026/05/15New drug · Class 1 注射用QLC5513 · No verified English nameCXSL2600531 Qilu Pharmaceutical Co., Ltd.
2026/05/14Import · Class 1 VAY736注射液 · No verified English nameJXSL2600115 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/05/14Import · Class 1 Enpatoran · No verified English nameJXHL2600178 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd.
2026/05/14Import · Class 1 LYT-100 (Deupirfenidone) · No verified English nameJXHL2600177 PureTech LYT 100 Inc. a subsidiary of PureTech Health LLC; IQVIA RDS (Shanghai) Co. Ltd.
2026/05/14Import · Class 2.4 LNP023胶囊 · No verified English nameJXHL2600176 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/05/14Generic · Class 3 Bempedoic Acid TabletsCYHS2601153 Gan Li Pharma Shandong Co., Ltd. romanized
2026/05/14Generic · Class 3 盐酸二甲双胍缓释片(Ⅳ) · No verified English nameCYHS2601148 De Zhou Bo Cheng Pharmaceutical Co., Ltd. romanized
2026/05/14Generic · Class 3 盐酸精氨酸注射液 · No verified English nameCYHS2601144 Sichuan Qi Yu Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2026/05/14Generic · Class 3 硝酸咪康唑散 · No verified English nameCYHS2601141 Jiangsu Ziyond Pharmaceutical Co., Ltd.
2026/05/14Generic · Class 3 硝酸咪康唑散 · No verified English nameCYHS2601140 Jiangsu Ziyond Pharmaceutical Co., Ltd.
2026/05/14Generic · Class 3 LevomilnacipranHydrochloride Extended-release CapsulesCYHS2601136 Jiangsu En Hua Pharma Co., Ltd. romanized; Jiangsu En Hua Sai De Pharma Co., Ltd. romanized
2026/05/14Generic · Class 3 LevomilnacipranHydrochloride Extended-release CapsulesCYHS2601135 Jiangsu En Hua Pharma Co., Ltd. romanized; Jiangsu En Hua Sai De Pharma Co., Ltd. romanized
2026/05/14Generic · Class 3 LevomilnacipranHydrochloride Extended-release CapsulesCYHS2601134 Jiangsu En Hua Pharma Co., Ltd. romanized; Jiangsu En Hua Sai De Pharma Co., Ltd. romanized
2026/05/14Generic · Class 3 Ketotifen Fumarate Oral SolutionCYHS2601132 Guangdong Nan Guo Pharma Co., Ltd. romanized
2026/05/14Generic · Class 3 右美沙芬安非他酮缓释片 · No verified English nameCYHS2601125 CSPC OUYI PHARMACEUTICAL CO., LTD.
2026/05/14New drug · Class 2.3 参芪温阳阴道膨胀栓 · No verified English nameCXZL2600044 Haerbin Tian Mei Pharma Co., Ltd. romanized
2026/05/14New drug · Class 1 WGc-043注射液 · No verified English nameCXSL2600530 Chengdu Wei Si Jin Biopharmaceuticals Technology Co., Ltd. romanized
2026/05/14New drug · Class 2.2 重组B群脑膜炎球菌疫苗(大肠杆菌) · No verified English nameCXSL2600529 Beijing Xian Sheng Xiang Rui Bio Zhi Pin Co., Ltd. romanized
2026/05/14New drug · Class 2.2 QL2107注射液 · No verified English nameCXSL2600528 Qilu Pharmaceutical Co., Ltd.
2026/05/14New drug · Class 3.2 人血管性血友病因子复合物 · No verified English nameCXSL2600527 Yuan Da Shu Yang Sheng Ming Ke Xue (Chengdu) Co., Ltd. romanized
2026/05/14New drug · Class 1 ZM-02眼用注射液 · No verified English nameCXSL2600526 Zhong Mou Medical Technology (Shanghai) Co., Ltd. romanized
2026/05/14New drug · Class 1 注射用SKB500 · No verified English nameCXSL2600525 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2026/05/14New drug · Class 1 SYS6043 · No verified English nameCXSL2600524 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2026/05/14New drug · Class 1 SYS6090注射液 · No verified English nameCXSL2600523 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2026/05/14New drug · Class 1 个性化树突状细胞注射液 · No verified English nameCXSL2600522 Zhong Sheng Kang Yuan Bio Technology (Beijing) Co., Ltd. romanized
2026/05/14New drug · Class 1 SCTB35注射液 · No verified English nameCXSL2600521 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2026/05/14New drug · Class 1 SCTB35注射液 · No verified English nameCXSL2600520 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2026/05/14New drug · Class 1 SCTB35注射液 · No verified English nameCXSL2600519 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized

114 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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