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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 384 drug applications between 29 January 2026 and 4 February 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 82, covering 59 drug names.

2026/01/29 – 2026/02/04

Period
2026/01/29 to 2026/02/04, 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
384
Drugs with new generic filings (by drug name, de-duplicated)
59
Accepted this week, now under review
122

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

384filings, 82 of them generic

By application type

Application typeFilings
Supplement210
Generic82
New drug59
Import16
Import re-registration9
Unspecified8

By drug type

Drug typeFilings
Chemical drug219
TCM106
Therapeutic biologic52
Prophylactic biologic4
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

59 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

217 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Ha Yao Group Bio Gong Cheng Co., Ltd. romanized1680
2Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized12120
3Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized930
4Shen Wei Pharma Group Co., Ltd. romanized660
5Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized660
6Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized640
7Bayer AG620
8Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized620
9Novo Nordisk A/S610
10Guangxi Wu Zhou Pharmaceutical (Group) Co., Ltd. romanized550

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

103 this week

AcceptedDrugApplicants
2026/02/04Generic · Class 3 Bifonazole SolutionCYHS2600356 Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized
2026/02/04Generic · Class 3 托吡酯口服溶液 · No verified English nameCYHS2600354 Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized
2026/02/04Generic · Class 3 Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHS2600353 Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized
2026/02/04Generic · Class 3 Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHS2600352 Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized
2026/02/04Generic · Class 3 Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHS2600351 Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized
2026/02/04Generic · Class 3 Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHS2600350 Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized
2026/02/04Generic · Class 3 Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHS2600349 Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized
2026/02/04Generic · Class 3 氨氯地平缬沙坦氢氯噻嗪片 · No verified English nameCYHL2600020 Chengdu Di Ao Pharmaceutical Group Co., Ltd. romanized
2026/02/04New drug · Class 1 IBI3031 · No verified English nameCXSL2600167 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/02/04New drug · Class 1 NEWR0919滴眼液 · No verified English nameCXSL2600166 Shenzhen Xin Rui Ji Yin Technology Co., Ltd. romanized
2026/02/04New drug · Class 1 NEWR0919滴眼液 · No verified English nameCXSL2600165 Shenzhen Xin Rui Ji Yin Technology Co., Ltd. romanized
2026/02/04New drug · Class 1 NEWR0919滴眼液 · No verified English nameCXSL2600164 Shenzhen Xin Rui Ji Yin Technology Co., Ltd. romanized
2026/02/04New drug · Class 2.4 芦沃美替尼片 · No verified English nameCXHS2600025 Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized
2026/02/04New drug · Class 2.4 芦沃美替尼片 · No verified English nameCXHS2600024 Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized
2026/02/04New drug · Class 2.2 HR091506片 · No verified English nameCXHS2600023 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/02/04New drug · Class 2.2 HR091506片 · No verified English nameCXHS2600022 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/02/04New drug · Class 1 甲磺酸奥达替尼胶囊 · No verified English nameCXHS2600021 Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized
2026/02/04New drug · Class 1 甲磺酸奥达替尼胶囊 · No verified English nameCXHS2600020 Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized
2026/02/04New drug · Class 1 SIR9900片 · No verified English nameCXHL2600144 Wei Tai Rui Long (Beijing) Bio Technology Co., Ltd. romanized
2026/02/04New drug · Class 1 JAB-8263片 · No verified English nameCXHL2600143 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2026/02/04New drug · Class 1 JAB-8263片 · No verified English nameCXHL2600142 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2026/02/03Import · Class 1 BI 764532 输注用浓缩粉末 · No verified English nameJXSL2600037 Boehringer lngelheim International GmbH; Boehringer lngelheim (China) Investment Co. Ltd.
2026/02/03Generic · Class 3 Ketorolac Trometamol TabletsCYHS2600346 Hunan Jiudian Pharmaceutical Co., Ltd
2026/02/03Generic · Class 3 Torsemide InjectionCYHS2600341 Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized
2026/02/03Generic · Class 3 盐酸舍曲林口服浓缩液 · No verified English nameCYHS2600340 Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2026/02/03Generic · Class 3 复方匹可硫酸钠颗粒 · No verified English nameCYHS2600339 Zhejiang Hao Ge Pharma Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2026/02/03New drug · Class 1 注射用GenSci136 · No verified English nameCXSL2600163 Changchun Jin Sai Pharma Co., Ltd. romanized
2026/02/03New drug · Class 1 注射用SHR-9839(sc) · No verified English nameCXSL2600162 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/02/03New drug · Class 2.2 SHR-8068注射液 · No verified English nameCXSL2600161 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/02/03New drug · Class 1 注射用SHR-1826 · No verified English nameCXSL2600160 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized

73 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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