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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 416 drug applications between 4 September 2026 and 10 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 66, covering 54 drug names.

2026/09/04 – 2026/09/10

Period
2026/09/04 to 2026/09/10, 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
416
Drugs with new generic filings (by drug name, de-duplicated)
54
Accepted this week, now under review
336

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

416filings, 66 of them generic

By application type

Application typeFilings
Supplement249
New drug79
Generic66
Import13
Import re-registration5
Unspecified4

By drug type

Drug typeFilings
Chemical drug191
TCM145
Therapeutic biologic75
Prophylactic biologic3
In vitro diagnostic reagent1
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

54 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sodium Bicarbonate Injection3210
2富马酸奥赛利定注射液 · No verified English name313
3Dotinurad Tablets2155
4Vonoprazan Fumarate Tablets2160
5Nilotinib Capsules216
6Ticagrelor Tablets2110
7Ambroxol Hydrochloride Oral Solution2146
8Fexofenadine Hydrochloride Tablets2110
9Ziprasidone Hydrochloride Capsules219
10Adapalene And Benzoyl Peroxide Gel2130

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

257 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Tai Ji Group Chongqing Tong Jun Ge Pharmaceutical Factory Co., Ltd. romanized13130
2Beijing Kang Nuo Ya Biopharmaceuticals Co., Ltd. romanized810
3Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized620
4Shenzhen Han Yu Pharma Co., Ltd. romanized610
5Jiangxi Hua Tai Pharma Co., Ltd. romanized550
6Henan Bai Nian Kang Xin Pharma Co., Ltd. romanized550
7Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized540
8Jilin Yu Ren Pharmaceutical Co., Ltd. romanized440
9Sichuan De Feng Pharma Co., Ltd. romanized440
10Xizang Jin Ha Da 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

117 this week

AcceptedDrugApplicants
2026/09/10Import · Class 2.1; 2.2 索特西普注射液 · No verified English nameJXSL2600241 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2026/09/10Import · Class 1 NCX 470滴眼液 · No verified English nameJXHS2600105 OCUMENSION(HONG KONG)LIMITED; Alliance Medical Products Inc. (dba. Siegfried Irvine); Ocumension Therapeutics(Suzhou)Co. Ltd.
2026/09/10Generic · Class 3 Bilastine Oral SolutionCYHS2602267 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2026/09/10Generic · Class 3 盐酸奥洛他定口崩片 · No verified English nameCYHS2602266 Hong Yue Technology (Hu Zhou) Co., Ltd. romanized; Zhejiang Hao Ge Pharma Co., Ltd. romanized
2026/09/10Generic · Class 3 Vardenafil Hydrochloride Orally disintegrating TabletsCYHS2602261 Beijing Ming Ze Zhong He Drug Research Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2026/09/10New drug · Class 3.1 温胆汤颗粒 · No verified English nameCXZS2600048 China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd.
2026/09/10New drug · Class 1.3 三价流感重组蛋白疫苗 · No verified English nameCXSL2600989 Zhuhai Shi Li Zhu Dan Kang Bio Technology Co., Ltd. romanized
2026/09/10New drug · Class 1.3 三价流感重组蛋白疫苗 · No verified English nameCXSL2600988 Zhuhai Shi Li Zhu Dan Kang Bio Technology Co., Ltd. romanized
2026/09/10New drug · Class 1 HLX109注射液 · No verified English nameCXSL2600987 Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized; Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized
2026/09/10New drug · Class 1 KHN923注射液 · No verified English nameCXSL2600986 Chengdu Kang Hong Bio Technology Co., Ltd. romanized
2026/09/10New drug · Class 1 MTS109注射液 · No verified English nameCXSL2600985 Ji Tai Technology (Beijing) Co., Ltd. romanized; Beijing Ji Tai Sheng Ming Technology Co., Ltd. romanized
2026/09/10New drug · Class 1 INT-1868片 · No verified English nameCXHL2601107 Yi Kun Xing Jian Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2026/09/10New drug · Class 1 INT-1868片 · No verified English nameCXHL2601106 Yi Kun Xing Jian Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2026/09/10New drug · Class 1 INT-1868片 · No verified English nameCXHL2601105 Yi Kun Xing Jian Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2026/09/09Generic · Class 3 Sodium Bicarbonate InjectionCYHS2602252 Shanxi Cheng Ze Yuan Bio Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2026/09/09Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2602251 Shandong Nuo He Kang Pharma Co., Ltd. romanized
2026/09/09Generic · Class 3 Triamcinolone Acetonide and Econazole Nitrate CreamCYHS2602250 Jiangsu Hua Han Pharmaceuticals Technology Co., Ltd. romanized; TC Pharmaceuticals (Jiangsu) Co., Ltd
2026/09/09New drug · Class 1 注射用SAL02681 · No verified English nameCXSL2600984 Nanjing Sai Le Si Biopharmaceutical Co., Ltd. romanized
2026/09/09New drug · Class 1 UGX202注射液 · No verified English nameCXSL2600983 Suzhou Xing Ming You Jian Bio Technology Co., Ltd. romanized
2026/09/09New drug · Class 1 注射用SAL02682 · No verified English nameCXSL2600982 Nanjing Sai Le Si Biopharmaceutical Co., Ltd. romanized
2026/09/09New drug · Class 1 SQ-25042眼内注射溶液 · No verified English nameCXSL2600981 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2026/09/09New drug · Class 1 SQ-25042眼内注射溶液 · No verified English nameCXSL2600980 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2026/09/09New drug · Class 1 SQ-25042眼内注射溶液 · No verified English nameCXSL2600979 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2026/09/09New drug · Class 1 异体3D间充质基质细胞注射液 · No verified English nameCXSL2600978 Jian Yuan (Beijing) Zai Sheng Yi Xue Technology Co., Ltd. romanized; Zhang Jia Kou Jian Yuan Jing Zhun Yi Xue Co., Ltd. romanized
2026/09/09New drug · Class 1 瑞普泊肽注射液 · No verified English nameCXHS2600129 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/09/09New drug · Class 1 瑞普泊肽注射液 · No verified English nameCXHS2600128 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/09/09New drug · Class 1 注射用GGA-sNIR · No verified English nameCXHL2601104 Guangzhou Shi Yun Bio Technology Co., Ltd. romanized
2026/09/09New drug · Class 1 ZL-65片 · No verified English nameCXHL2601103 Chengdu Ze Ling Biopharmaceuticals Technology Co., Ltd. romanized
2026/09/09New drug · Class 1 ZL-65片 · No verified English nameCXHL2601102 Chengdu Ze Ling Biopharmaceuticals Technology Co., Ltd. romanized
2026/09/09New drug · Class 1 ZL-65片 · No verified English nameCXHL2601101 Chengdu Ze Ling Biopharmaceuticals Technology Co., Ltd. romanized

87 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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