YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 428 drug applications between 10 September 2026 and 16 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 63, covering 47 drug names.

2026/09/10 – 2026/09/16

Period
2026/09/10 to 2026/09/16, 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
428
Drugs with new generic filings (by drug name, de-duplicated)
47
Accepted this week, now under review
369

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

428filings, 63 of them generic

By application type

Application typeFilings
Supplement241
New drug89
Generic63
Import22
Unspecified7
Import re-registration6

By drug type

Drug typeFilings
Chemical drug198
TCM141
Therapeutic biologic82
Prophylactic biologic5
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

47 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

271 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shaanxi Hua Xi Pharmaceutical Co., Ltd. romanized990
2Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized850
3F. Hoffmann-La Roche Ltd720
4Bo Hui Biopharmaceutical (Yunnan) Co., Ltd. romanized650
5Novo Nordisk A/S620
6Ning Kang Rui Zhu Biopharmaceutical (Zhuhai) Co., Ltd. romanized620
7Novartis Pharma AG530
8Beijing Tong Ren Tang Co., Ltd. Tong Ren Tang Pharmaceutical Factory romanized530
9Jiangxi Pin Xin Pharma Co., Ltd. romanized520
10Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized510

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

131 this week

AcceptedDrugApplicants
2026/09/16Import · Class 2.2 Amivantamab注射液(皮下注射) · No verified English nameJXSL2600248 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/09/16Import · Class 2.2 Amivantamab注射液(皮下注射) · No verified English nameJXSL2600247 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/09/16Import · Class 2.2 斯贝利单抗注射液(皮下注射) · No verified English nameJXSL2600246 Otsuka Pharmaceutical Development & Commercialization Inc.; Otsuka Beijing Research Institute
2026/09/16Import · Class 2.2 斯贝利单抗注射液(皮下注射) · No verified English nameJXSL2600245 Otsuka Pharmaceutical Development & Commercialization Inc.; Otsuka Beijing Research Institute
2026/09/16Import · Class 1 DKB903注射用浓溶液 · No verified English nameJXSL2600244 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/09/16Import · Class 2.2 格菲妥单抗注射液 · No verified English nameJXSL2600243 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/09/16Import · Class 1 BMS-986504片 · No verified English nameJXHL2600409 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/09/16Generic · Class 3 头孢泊肟酯干混悬剂 · No verified English nameCYHS2602308 Hainan Ri Zhong Tian Pharmaceutical Co., Ltd. romanized
2026/09/16Generic · Class 3 Emedastine Difumarate Sustained-release CapsulesCYHS2602307 Beijing Bai Ao Pharma Co., Ltd. romanized
2026/09/16Generic · Class 3 Emedastine Difumarate Sustained-release CapsulesCYHS2602306 Beijing Bai Ao Pharma Co., Ltd. romanized
2026/09/16Generic · Class 3 Vasopressin InjectionCYHS2602302 Guangdong Tian Pu Sheng Hua Pharmaceuticals Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2026/09/16Generic · Class 3 Simethicone Chewable TabletsCYHS2602293 Zhengzhou Rui Kang Pharmaceutical Co., Ltd. romanized
2026/09/16Generic · Class 3 塞来昔布盐酸曲马多片 · No verified English nameCYHL2600101 Hefei Li Fang Pharmaceutical Co., Ltd. romanized
2026/09/16Generic · Class 3 司美格鲁肽注射液 · No verified English nameCYHL2600100 Tianjin Tian Shi Li Zhi Jiao Pharma Co., Ltd. romanized
2026/09/16Generic · Class 3 司美格鲁肽注射液 · No verified English nameCYHL2600099 Tianjin Tian Shi Li Zhi Jiao Pharma Co., Ltd. romanized
2026/09/16Generic · Class 3 司美格鲁肽注射液 · No verified English nameCYHL2600098 Tianjin Tian Shi Li Zhi Jiao Pharma Co., Ltd. romanized
2026/09/16New drug · Class 1.1 青术颗粒 · No verified English nameCXZS2600050 Tian Shi Li Pharmaceuticals Group Co., Ltd. romanized
2026/09/16New drug · Class 2.2 普特利单抗注射液 · No verified English nameCXSS2600152 Le Pu Bio Technology Co., Ltd. romanized; Ding Kang (Wuhan) Biopharmaceuticals Co., Ltd. romanized
2026/09/16New drug · Class 1 注射用SIM0688 · No verified English nameCXSL2601015 Shanghai Xian Sheng Zai Ming Technology Co., Ltd. romanized
2026/09/16New drug · Class 1 IBI324 · No verified English nameCXSL2601014 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/09/16New drug · Class 1 注射用BNT3211 · No verified English nameCXSL2601013 Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized
2026/09/16New drug · Class 1 注射用YL201 · No verified English nameCXSL2601012 Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized
2026/09/16New drug · Class 1 注射用SKB571 · No verified English nameCXSL2601011 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2026/09/16New drug · Class 1 SKB118注射液 · No verified English nameCXSL2601010 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2026/09/16New drug · Class 1 YB001凝胶 · No verified English nameCXSL2601009 Mu Dan Jiang You Bo Pharma Co., Ltd. romanized
2026/09/16New drug · Class 1 YB001凝胶 · No verified English nameCXSL2601008 Mu Dan Jiang You Bo Pharma Co., Ltd. romanized
2026/09/16New drug · Class 1 KM1溶瘤痘苗病毒注射液 · No verified English nameCXSL2601005 Shenzhen Shi Hua Yao Kang Ming Bio Pharma Co., Ltd. romanized
2026/09/16New drug · Class 1 IBI3005 · No verified English nameCXSL2601003 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/09/16New drug · Class 1 GV20-0251注射液 · No verified English nameCXSL2601002 Shanghai Xun Bai Hui Bio Technology Co., Ltd. romanized
2026/09/16New drug · Class 1 YTS109细胞注射液 · No verified English nameCXSL2601001 Hua Xia Ying Tai (Beijing) Bio Technology Co., Ltd. romanized; Hua Xia Ying Tai (Beijing) Pharmaceuticals Technology Co., Ltd. romanized

101 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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