YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 463 drug applications between 11 September 2026 and 17 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 60, covering 43 drug names.
2026/09/11 – 2026/09/17
- New acceptances this week
- 463
- Drugs with new generic filings (by drug name, de-duplicated)
- 43
- Accepted this week, now under review
- 401
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
463filings, 60 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 264 |
| New drug | 103 |
| Generic | 60 |
| Import | 21 |
| Unspecified | 9 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 209 |
| TCM | 156 |
| Therapeutic biologic | 91 |
| Biologic | 4 |
| Prophylactic biologic | 3 |
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
43 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ruxolitinib Phosphate Tablets | 4 | 1 | 27 |
| 2 | Emedastine Difumarate Sustained-release Capsules | 3 | 2 | 11 |
| 3 | 司美格鲁肽注射液 · No verified English name | 3 | 1 | 92 |
| 4 | 盐酸金刚烷胺口服溶液 · No verified English name | 3 | 1 | 3 |
| 5 | Polidocanol Injection | 3 | 1 | 23 |
| 6 | Tranexamic Acid Injection | 2 | 1 | 11 |
| 7 | Oseltamivir Phosphate Capsules | 2 | 1 | 39 |
| 8 | Sulindac Tablets | 2 | 1 | 5 |
| 9 | Mirogabalin Besilate Tablets | 2 | 1 | 61 |
| 10 | 褪黑素颗粒 · No verified English name | 2 | 1 | 12 |
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
275 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 9 | 6 | 0 |
| 2 | Tai Ji Group Chongqing Tong Jun Ge Pharmaceutical Factory Co., Ltd. romanized | 8 | 7 | 0 |
| 3 | Shaanxi Hua Xi Pharmaceutical Co., Ltd. romanized | 7 | 7 | 0 |
| 4 | F. Hoffmann-La Roche Ltd | 7 | 2 | 0 |
| 5 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 7 | 2 | 0 |
| 6 | Bo Hui Biopharmaceutical (Yunnan) Co., Ltd. romanized | 6 | 5 | 0 |
| 7 | Novo Nordisk A/S | 6 | 2 | 0 |
| 8 | Ning Kang Rui Zhu Biopharmaceutical (Zhuhai) Co., Ltd. romanized | 6 | 2 | 0 |
| 9 | Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized | 6 | 2 | 0 |
| 10 | Novartis Pharma AG | 5 | 3 | 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
142 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/09/17Import · Class 1 | PF-08046876 · No verified English nameJXSL2600249 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/09/17Generic · Class 3 | Emedastine Difumarate Sustained-release CapsulesCYHS2602313 | Sichuan Bei Ling He Yi Pharmaceutical Co., Ltd. romanized |
| 2026/09/17New drug · Class 1 | IBI3043 · No verified English nameCXSL2601020 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2026/09/17New drug · Class 2.2 | 注射用波米泰酶α · No verified English nameCXSL2601019 | Jiangsu Bei Jie Tai Bio Technology Co., Ltd. romanized |
| 2026/09/17New drug · Class 1 | ASP1002注射液 · No verified English nameCXSL2601018 | An Si Tai Lai (Beijing) Pharmaceuticals Research and Development Co., Ltd. romanized |
| 2026/09/17New drug · Class 1 | ASP1002注射液 · No verified English nameCXSL2601017 | An Si Tai Lai (Beijing) Pharmaceuticals Research and Development Co., Ltd. romanized |
| 2026/09/17New drug · Class 1 | 注射用HX111 · No verified English nameCXSL2601016 | Han Si Ai Tai Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized |
| 2026/09/17New drug · Class 1 | YH001胶囊 · No verified English nameCXHL2601166 | Hangzhou Yu Hong Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/17New drug · Class 1 | YH001胶囊 · No verified English nameCXHL2601165 | Hangzhou Yu Hong Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/17New drug · Class 1 | RSS0343胶囊 · No verified English nameCXHL2601164 | Rui Shi Biopharmaceuticals Co., Ltd. romanized |
| 2026/09/17New drug · Class 1 | RSS0343胶囊 · No verified English nameCXHL2601163 | Rui Shi Biopharmaceuticals Co., Ltd. romanized |
| 2026/09/17New drug · Class 1 | RSS0343胶囊 · No verified English nameCXHL2601162 | Rui Shi Biopharmaceuticals Co., Ltd. romanized |
| 2026/09/17New drug · Class 1 | RSS0343胶囊 · No verified English nameCXHL2601161 | Rui Shi Biopharmaceuticals Co., Ltd. romanized |
| 2026/09/17New drug · Class 1 | 注射用SR14肽 · No verified English nameCXHL2601160 | Zhongguo Ke College Kunming Dong Wu Research Institute romanized |
| 2026/09/17New drug · Class 1 | IKT-001片 · No verified English nameCXHL2601159 | Nuo Wei Tai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/09/17New drug · Class 2.4 | Daraxonrasib片 · No verified English nameCXHL2601158 | Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized |
| 2026/09/17New drug · Class 2.4 | Daraxonrasib片 · No verified English nameCXHL2601157 | Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized |
| 2026/09/17New drug · Class 2.4 | Daraxonrasib片 · No verified English nameCXHL2601156 | Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized |
| 2026/09/17New drug · Class 2.4 | Daraxonrasib片 · No verified English nameCXHL2601155 | Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized |
| 2026/09/17New drug · Class 2.2 | LP095口颊膜 · No verified English nameCXHL2601154 | Li Pin Pharma (Xiamen) Co., Ltd. romanized |
| 2026/09/17New drug · Class 2.2 | LP095口颊膜 · No verified English nameCXHL2601153 | Li Pin Pharma (Xiamen) Co., Ltd. romanized |
| 2026/09/17New drug · Class 2.2 | LP095口颊膜 · No verified English nameCXHL2601152 | Li Pin Pharma (Xiamen) Co., Ltd. romanized |
| 2026/09/17New drug · Class 1 | TQB3306 片 · No verified English nameCXHL2601151 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2026/09/17New drug · Class 1 | TQB3306片 · No verified English nameCXHL2601150 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2026/09/17New drug · Class 2.4 | 林普利塞片 · No verified English nameCXHL2601149 | Shanghai Ying Li Pharma Co., Ltd. romanized |
| 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. |
112 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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