YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 466 drug applications between 15 July 2026 and 21 July 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 78, covering 53 drug names.
2026/07/15 – 2026/07/21
- New acceptances this week
- 466
- Drugs with new generic filings (by drug name, de-duplicated)
- 53
- Accepted this week, now under review
- 161
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
466filings, 78 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 287 |
| Generic | 78 |
| New drug | 65 |
| Import | 22 |
| Unspecified | 8 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 234 |
| TCM | 153 |
| Therapeutic biologic | 69 |
| Prophylactic biologic | 8 |
| 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
53 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Dotinurad Tablets | 5 | 2 | 55 |
| 2 | Baricitinib Tablets | 4 | 2 | 32 |
| 3 | Brivaracetam Tablets | 3 | 1 | 19 |
| 4 | Emedastine Difumarate Eye Drops | 2 | 2 | 9 |
| 5 | 布美他尼片 · No verified English name | 2 | 2 | 8 |
| 6 | 瑞维那新吸入溶液 · No verified English name | 2 | 2 | 53 |
| 7 | Buprenorphine Transdermal Patches | 2 | 1 | 6 |
| 8 | Ethyl Iosapentate Capsules | 2 | 1 | 27 |
| 9 | Gatifloxacin Eye Drops | 2 | 1 | 3 |
| 10 | Oxaliplatin Injection | 2 | 1 | 4 |
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
274 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Ji Er Ji Pharma Co., Ltd. romanized | 10 | 10 | 0 |
| 2 | Jiangxi Jiu Lian Shan Pharma Co., Ltd. romanized | 10 | 9 | 0 |
| 3 | Qinghai Di Ma Er Zang Yao Pharma Co., Ltd. romanized | 9 | 9 | 0 |
| 4 | Pfizer Inc. | 7 | 3 | 0 |
| 5 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 7 | 2 | 0 |
| 6 | An Kang Zheng Da Pharmaceutical Co., Ltd. romanized | 6 | 5 | 0 |
| 7 | Fresenius Kabi Austria GmbH | 6 | 1 | 0 |
| 8 | Shanxi Hua Kang Pharma Co., Ltd. romanized | 5 | 4 | 0 |
| 9 | Novo Nordisk A/S | 5 | 2 | 0 |
| 10 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 5 | 2 | 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
114 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/07/21Import · Class 1 | PF-08634404 · No verified English nameJXSL2600173 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/07/21Import · Class 1 | MK-4716片 · No verified English nameJXHL2600282 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2026/07/21Import · Class 1 | MK-4716片 · No verified English nameJXHL2600281 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2026/07/21Import · Class 1 | MK-4716片 · No verified English nameJXHL2600280 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2026/07/21Generic · Class 3 | 布美他尼片 · No verified English nameCYHS2601746 | Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized |
| 2026/07/21Generic · Class 3 | Nystatin Oral SuspensionCYHS2601742 | Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Tong Da Pharma Co., Ltd. romanized |
| 2026/07/21Generic · Class 3 | 富马酸伊布利特注射液 · No verified English nameCYHS2601741 | Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized |
| 2026/07/21New drug · Class 3.1 | 温经汤颗粒 · No verified English nameCXZS2600037 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2026/07/21New drug · Class 1 | 金妥昔单抗注射液 · No verified English nameCXSS2600110 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2026/07/21New drug · Class 1 | 注射用VBC117 · No verified English nameCXSL2600753 | Shanghai Cheng Fan Pharmaceuticals Co., Ltd. romanized |
| 2026/07/21New drug · Class 2.3 | 沙库巴曲阿利沙坦氨氯地平片 · No verified English nameCXHS2600105 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2026/07/21New drug · Class 1 | IBI3042 · No verified English nameCXHL2600890 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2026/07/21New drug · Class 1 | IBI3042 · No verified English nameCXHL2600889 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2026/07/21New drug · Class 1 | IBI3042 · No verified English nameCXHL2600888 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2026/07/21New drug · Class 1 | IBI3042 · No verified English nameCXHL2600887 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2026/07/21New drug · Class 1 | BG-75098片 · No verified English nameCXHL2600886 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2026/07/21New drug · Class 1 | BG-75098片 · No verified English nameCXHL2600885 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2026/07/21New drug · Class 1 | BG-75098片 · No verified English nameCXHL2600884 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2026/07/21New drug · Class 1 | BGB-43395片 · No verified English nameCXHL2600883 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2026/07/21New drug · Class 1 | BGB-43395片 · No verified English nameCXHL2600882 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2026/07/21New drug · Class 1 | BGB-43395片 · No verified English nameCXHL2600881 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2026/07/21New drug · Class 1 | BGB-43395片 · No verified English nameCXHL2600880 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2026/07/20Import · Class 3.1 | 伊匹木单抗注射液 · No verified English nameJXSS2600063 | Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Samsung Biologics Co. Ltd; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2026/07/20Import · Class 1 | AZD5335 · No verified English nameJXSL2600172 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/07/20Import · Class 2.4 | 贝组替凡片 · No verified English nameJXHL2600279 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2026/07/20Import · Class 2.4 | 塞伐艾替尼片 · No verified English nameJXHL2600278 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2026/07/20Import · Class 2.4 | 塞伐艾替尼片 · No verified English nameJXHL2600277 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2026/07/20Generic · Class 3 | Esketamine Hydrochloride InjectionCYHS2601737 | Guo Yao Group Gong Ye Co., Ltd. Lang Fang Branch romanized |
| 2026/07/20Generic · Class 3 | 布美他尼片 · No verified English nameCYHS2601736 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2026/07/20Generic · Class 3 | Potassium Chloride InjectionCYHS2601732 | Jinan Kang Qiao Pharmaceuticals Technology Co., Ltd. romanized; Xian Li Jun Kang Le Pharmaceutical Co., Ltd. romanized |
84 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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