YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 502 drug applications between 19 December 2025 and 25 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 99, covering 70 drug names.
2025/12/19 – 2025/12/25
- New acceptances this week
- 502
- Drugs with new generic filings (by drug name, de-duplicated)
- 70
- Accepted this week, now under review
- 106
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
502filings, 99 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 234 |
| New drug | 118 |
| Generic | 99 |
| Import | 18 |
| Import re-registration | 17 |
| Unspecified | 16 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 267 |
| TCM | 129 |
| Therapeutic biologic | 94 |
| Biologic | 6 |
| Prophylactic biologic | 6 |
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
70 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Baricitinib Tablets | 3 | 2 | 32 |
| 2 | Vortioxetine Hydrobromide Tablets | 3 | 2 | 10 |
| 3 | Dapagliflozin Tablets | 3 | 2 | 84 |
| 4 | Lidocaine and Prilocaine Cream | 3 | 1 | 24 |
| 5 | Sildenafil Citrate Tablets | 3 | 1 | 12 |
| 6 | Oseltamivir Phosphate Capsules | 3 | 1 | 39 |
| 7 | 草酸艾司西酞普兰口服溶液 · No verified English name | 3 | 1 | 11 |
| 8 | 西诺氨酯片 · No verified English name | 3 | 1 | 24 |
| 9 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 10 | Ilaprazole Enteric-coated Tablets | 2 | 2 | 26 |
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
267 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Sheng De Shang Pharma Co., Ltd. romanized | 37 | 31 | 0 |
| 2 | Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized | 17 | 17 | 0 |
| 3 | Amgen Inc. | 13 | 2 | 0 |
| 4 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized | 10 | 2 | 0 |
| 5 | AstraZeneca AB | 9 | 5 | 0 |
| 6 | medac Gesellschaft für klinische Spezialpr?parate mbH | 8 | 1 | 0 |
| 7 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 8 | 1 | 0 |
| 8 | Merck Sharp & Dohme LLC | 7 | 4 | 0 |
| 9 | Hunan Jiudian Pharmaceutical Co., Ltd | 6 | 5 | 1 |
| 10 | Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized | 5 | 5 | 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
164 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/12/25Import · Class 1 | BCD-261注射液 · No verified English nameJXSL2500249 | SPH-BIOCAD(HK)LIMITED; SPH-BIOCAD Biopharmaceuticals (SH) Co. Ltd. |
| 2025/12/25Import · Class 2.2 | MK-3475A注射液 · No verified English nameJXSL2500248 | Merck Sharp & Dohme B.V.; MSD R&D (China) Co. Ltd |
| 2025/12/25Import · Class 2.2 | MK-3475A注射液 · No verified English nameJXSL2500247 | Merck Sharp & Dohme B.V.; MSD R&D (China) Co. Ltd |
| 2025/12/25Import · Class 2.2 | 伊奈利珠单抗注射液 · No verified English nameJXSL2500246 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2025/12/25Import · Class 1 | MK-1084片 · No verified English nameJXHL2500395 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2025/12/25Import · Class 1 | MK-1084片 · No verified English nameJXHL2500394 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2025/12/25Import · Class 1 | Zorevunersen注射液 · No verified English nameJXHL2500393 | Stoke Therapeutics Inc.; IQVIA RDS (Shanghai) Co. Ltd. |
| 2025/12/25Import · Class 1 | Zorevunersen注射液 · No verified English nameJXHL2500392 | Stoke Therapeutics Inc.; IQVIA RDS (Shanghai) Co. Ltd. |
| 2025/12/25Generic · Class 3 | Venlafaxine Hydrochloride Extended Release TabletsCYHS2504406 | TIANJIN LISHENG PHARMACEUTICAL CO., LTD |
| 2025/12/25Generic · Class 3 | Pazufloxacin Mesylate InjectionCYHS2504399 | Hunan Jin Jian Pharma Co., Ltd. romanized |
| 2025/12/25Generic · Class 3 | Pazufloxacin Mesylate InjectionCYHS2504398 | Hunan Jin Jian Pharma Co., Ltd. romanized |
| 2025/12/25Generic · Class 3 | Mesalazine Sustained-release GranulesCYHS2504391 | Hunan Jiudian Pharmaceutical Co., Ltd |
| 2025/12/25Generic · Class 3 | Benazepril Hydrochloride and Hydrochlorothiazide TabletsCYHS2504390 | Anhui Jia He Pharma Co., Ltd. romanized |
| 2025/12/25Generic · Class 3 | Multiple Electrolytes and Sodium Acetate InjectionCYHS2504389 | Hai Tao Xin Yao Research and Development (Jiangsu) Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2025/12/25Generic · Class 3 | Doxycycline Hyclate TabletsCYHS2504388 | Zhejiang Yi Han Pharmaceutical Co., Ltd. romanized |
| 2025/12/25Generic · Class 3 | 左羟丙哌嗪口服溶液 · No verified English nameCYHS2504387 | Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2025/12/25Generic · Class 3 | Pyridostigmine Bromide TabletsCYHS2504383 | Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized |
| 2025/12/25Generic · Class 3 | Emedastine Difumarate Sustained-release CapsulesCYHS2504381 | Mu Yuan (Anhui) Pharma Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized |
| 2025/12/25Generic · Class 3 | Emedastine Difumarate Sustained-release CapsulesCYHS2504379 | Mu Yuan (Anhui) Pharma Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized |
| 2025/12/25New drug · Class 1 | SKB575(HBM7575)注射液 · No verified English nameCXSL2501137 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized; He Bo Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2025/12/25New drug · Class 1 | 注射用SG1827 · No verified English nameCXSL2501133 | Hangzhou Shang Jian Bio Technology Co., Ltd. romanized |
| 2025/12/25New drug · Class 1.2 | LVRNA015 · No verified English nameCXSL2501132 | Zhuhai Li Fan Da Bio Technology Co., Ltd. romanized |
| 2025/12/25New drug · Class 1 | 注射用BG-C477 · No verified English nameCXSL2501131 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2025/12/25New drug · Class 1 | HLX3901注射液 · No verified English nameCXSL2501130 | Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized |
| 2025/12/25New drug · Class 1 | LYW2402-NS-HK人源基质细胞注射液(三维工艺制备) · No verified English nameCXSL2501129 | Liaoning Yi Xue Zhen Liao Technology Research and Development Center Co., Ltd. romanized |
| 2025/12/25New drug · Class 2.4 | 注射用BAT1006 · No verified English nameCXSL2501128 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2025/12/25New drug · Class 1 | 注射用BAT8008 · No verified English nameCXSL2501127 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2025/12/25New drug · Class 1 | ICG366 CAR-T细胞注射液 · No verified English nameCXSL2501126 | Song He Mian Yi Bio Medical (Shenzhen) Co., Ltd. romanized |
| 2025/12/25New drug · Class 1 | QBR202眼内注射液 · No verified English nameCXSL2501125 | Xun Ji Bio Technology (Beijing) Co., Ltd. romanized |
| 2025/12/25New drug · Class 1 | QBR202眼内注射液 · No verified English nameCXSL2501124 | Xun Ji Bio Technology (Beijing) Co., Ltd. romanized |
134 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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