YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 323 drug applications between 14 October 2026 and 20 October 2026 (data as of 14 November 2026 06:00). Of these, generic applications numbered 59, covering 44 drug names.
2026/10/14 – 2026/10/20
- New acceptances this week
- 323
- Drugs with new generic filings (by drug name, de-duplicated)
- 44
- Accepted this week, now under review
- 288
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
323filings, 59 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 155 |
| New drug | 79 |
| Generic | 59 |
| Import | 13 |
| Unspecified | 11 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 172 |
| TCM | 82 |
| Therapeutic biologic | 60 |
| Biologic | 5 |
| Prophylactic biologic | 4 |
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
44 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ruxolitinib Phosphate Tablets | 3 | 1 | 27 |
| 2 | Propranolol hydrochloride oral solution | 2 | 2 | 4 |
| 3 | Tacrolimus Sustained-release Capsules | 2 | 1 | 6 |
| 4 | Dotinurad Tablets | 2 | 1 | 55 |
| 5 | 注射用托伐普坦磷酸钠 · No verified English name | 2 | 1 | 15 |
| 6 | Betahistine Dihydrochloride Tablets | 2 | 1 | 11 |
| 7 | Arginine and Ibuprofen Granules | 2 | 1 | 11 |
| 8 | 苯磺酸左氨氯地平片 · No verified English name | 2 | 1 | 45 |
| 9 | Mirogabalin Besilate Tablets | 2 | 1 | 61 |
| 10 | Bimatoprost Eye Drops | 2 | 1 | 3 |
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
219 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Eli Lilly and Company | 14 | 5 | 0 |
| 2 | Changchun Jin Sai Pharma Co., Ltd. romanized | 6 | 2 | 0 |
| 3 | Shanxi Huang He Zhong Yao Co., Ltd. romanized | 5 | 5 | 0 |
| 4 | Medice Arzneimittel Pütter GmbH & Co. KG | 5 | 1 | 0 |
| 5 | Nei Menggu Tian Qi Zhong Meng Pharmaceutical Co., Ltd. romanized | 4 | 3 | 0 |
| 6 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 7 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 8 | Li Lai Suzhou Pharmaceutical Co., Ltd. (Bi Xin Manufacturing) romanized | 4 | 1 | 0 |
| 9 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | Cheng De Tian Yuan Pharma Co., Ltd. romanized | 3 | 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
110 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/10/20Import · Class 1 | Tilrekimig注射液 · No verified English nameJXSL2600276 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2026/10/20New drug · Class 1 | GenSci155注射液 · No verified English nameCXSL2601149 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2026/10/20New drug · Class 1 | GenSci155注射液 · No verified English nameCXSL2601148 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2026/10/20New drug · Class 2.3 | 多替拉韦拉米夫定替诺福韦片 · No verified English nameCXHS2600142 | Jiangsu Ai Di Pharma Group Co., Ltd. romanized |
| 2026/10/20New drug · Class 1 | 注射用BPI-585771 · No verified English nameCXHL2601308 | Bei Da Pharma Co., Ltd. romanized |
| 2026/10/19Import · Class 2.2 | 塔奎妥单抗注射液 · No verified English nameJXSS2600097 | Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd. |
| 2026/10/19Import · Class 2.2 | 塔奎妥单抗注射液 · No verified English nameJXSS2600096 | Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd. |
| 2026/10/19Import · Class 1 | ASP2138注射液 · No verified English nameJXSL2600275 | Astellas Pharma Global Development Inc.; Astellas (Beijing) Pharmaceutical R&D Co. Ltd. |
| 2026/10/19Import · Class 1 | Alnuctamab注射液 · No verified English nameJXSL2600274 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/10/19Import · Class 1 | Alnuctamab注射液 · No verified English nameJXSL2600273 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/10/19Generic · Class 3 | Landiolol Hydrochloride for InjectionCYHS2602574 | Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized |
| 2026/10/19Generic · Class 3 | Avanafil TabletsCYHS2602570 | Kunming Ji Da Pharmaceutical Co., Ltd. romanized |
| 2026/10/19Generic · Class 3 | Avanafil TabletsCYHS2602569 | Kunming Ji Da Pharmaceutical Co., Ltd. romanized |
| 2026/10/19Generic · Class 3 | MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2602564 | Hubei Duo Rui Pharma Co., Ltd. romanized; Zhejiang Guo Jing Pharma Co., Ltd. romanized |
| 2026/10/19Generic · Class 3 | Diphenhydramine Hydrochloride TabletsCYHS2602562 | Henan Lang Guan Medicines Formulations Research Institute Co., Ltd. romanized; Anhui Hua Chen Pharmaceutical Co., Ltd. romanized |
| 2026/10/19New drug · Class 2.3 | 济川煎颗粒 · No verified English nameCXZL2600101 | Hefei Hua Run Shen Lu Pharma Co., Ltd. romanized; Anhui Sheng Shi Pin Medicines Jian Yan Research Institute romanized |
| 2026/10/19New drug · Class 1 | SHR-5670注射液 · No verified English nameCXSL2601147 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Beijing Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/10/19New drug · Class 1 | 注射用TQB6411 · No verified English nameCXSL2601146 | Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2026/10/19New drug · Class 1 | 重组抗NKG2A人源化单克隆抗体注射液 · No verified English nameCXSL2601145 | Shanghai Huai Yue Bio Technology Co., Ltd. romanized |
| 2026/10/19New drug · Class 1 | B1962注射液 · No verified English nameCXSL2601144 | Tian Shi Li Biopharmaceuticals Co., Ltd. romanized |
| 2026/10/19New drug · Class 1 | B1962注射液 · No verified English nameCXSL2601143 | Tian Shi Li Biopharmaceuticals Co., Ltd. romanized |
| 2026/10/19New drug · Class 1 | SHR-5670注射液 · No verified English nameCXSL2601142 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Beijing Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/10/19New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2601141 | Guangzhou Bai Yun Shan Bai Di Biopharmaceuticals Co., Ltd. romanized |
| 2026/10/19New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2601140 | Guangzhou Bai Yun Shan Bai Di Biopharmaceuticals Co., Ltd. romanized |
| 2026/10/19New drug · Class 1 | 注射用LY4170156 · No verified English nameCXSL2601139 | Li Lai Suzhou Pharmaceutical Co., Ltd. romanized |
| 2026/10/19New drug · Class 1 | 联格列净片 · No verified English nameCXHS2600141 | Jiangsu Lianhuan Pharmaceutical Co.,Ltd. |
| 2026/10/19New drug · Class 1 | 联格列净片 · No verified English nameCXHS2600140 | Jiangsu Lianhuan Pharmaceutical Co.,Ltd. |
| 2026/10/19New drug · Class 1 | PA-XP-102 · No verified English nameCXHL2601307 | Zhong Ke Shuai Tian Pharmaceuticals (Shenzhen) Co., Ltd. romanized |
| 2026/10/19New drug · Class 1 | HPN-01肠溶胶囊 · No verified English nameCXHL2601306 | He Bo Heng Sheng (Shanghai) Pharmaceuticals Co., Ltd. romanized |
| 2026/10/19New drug · Class 1 | HPN-01肠溶胶囊 · No verified English nameCXHL2601305 | He Bo Heng Sheng (Shanghai) Pharmaceuticals Co., Ltd. romanized |
80 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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