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
- 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 type | Filings |
|---|---|
| Supplement | 241 |
| New drug | 89 |
| Generic | 63 |
| Import | 22 |
| Unspecified | 7 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 198 |
| TCM | 141 |
| Therapeutic biologic | 82 |
| Prophylactic biologic | 5 |
| Biologic | 2 |
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
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 司美格鲁肽注射液 · No verified English name | 3 | 1 | 92 |
| 2 | 盐酸金刚烷胺口服溶液 · No verified English name | 3 | 1 | 3 |
| 3 | Polidocanol Injection | 3 | 1 | 23 |
| 4 | Indacaterol Maleate and Glycopyrronium Bromide Powder for Inhalation | 2 | 2 | 3 |
| 5 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 6 | Emedastine Difumarate Sustained-release Capsules | 2 | 1 | 11 |
| 7 | Nilotinib Capsules | 2 | 1 | 6 |
| 8 | Ziprasidone Hydrochloride Capsules | 2 | 1 | 9 |
| 9 | Oseltamivir Phosphate Capsules | 2 | 1 | 39 |
| 10 | Sulindac Tablets | 2 | 1 | 5 |
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) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shaanxi Hua Xi Pharmaceutical Co., Ltd. romanized | 9 | 9 | 0 |
| 2 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 8 | 5 | 0 |
| 3 | F. Hoffmann-La Roche Ltd | 7 | 2 | 0 |
| 4 | Bo Hui Biopharmaceutical (Yunnan) Co., Ltd. romanized | 6 | 5 | 0 |
| 5 | Novo Nordisk A/S | 6 | 2 | 0 |
| 6 | Ning Kang Rui Zhu Biopharmaceutical (Zhuhai) Co., Ltd. romanized | 6 | 2 | 0 |
| 7 | Novartis Pharma AG | 5 | 3 | 0 |
| 8 | Beijing Tong Ren Tang Co., Ltd. Tong Ren Tang Pharmaceutical Factory romanized | 5 | 3 | 0 |
| 9 | Jiangxi Pin Xin Pharma Co., Ltd. romanized | 5 | 2 | 0 |
| 10 | Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized | 5 | 1 | 0 |
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
| Accepted | Drug | Applicants |
|---|---|---|
| 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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