YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 270 drug applications between 16 August 2022 and 22 August 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 61, covering 41 drug names.
2022/08/16 – 2022/08/22
- New acceptances this week
- 270
- Drugs with new generic filings (by drug name, de-duplicated)
- 41
- Accepted this week, now under review
- 0
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
270filings, 61 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 128 |
| Generic | 61 |
| New drug | 34 |
| Import | 21 |
| Import re-registration | 17 |
| Unspecified | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 211 |
| Therapeutic biologic | 36 |
| TCM | 20 |
| Biologic | 2 |
| Prophylactic biologic | 1 |
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
41 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 泊马度胺胶囊 · No verified English name | 4 | 1 | 4 |
| 2 | Montelukast Sodium Chewable Tablets | 3 | 2 | 4 |
| 3 | Sodium Bicarbonate Ringer’s Injection | 3 | 2 | 1 |
| 4 | Oseltamivir Phosphate Capsules | 3 | 1 | 39 |
| 5 | Sitagliptin Phosphate Tablets | 3 | 1 | 2 |
| 6 | Gadopentetic Acid Dimeglumine Salt Injection | 3 | 1 | 9 |
| 7 | Acetylcysteine Solution For Inhalation | 2 | 2 | 4 |
| 8 | Tadalafil Tablets | 2 | 1 | 23 |
| 9 | Entecavir Tablets | 2 | 1 | 0 |
| 10 | Sevelamer Carbonate Powder for oral suspension | 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
167 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hubei Hui Hai Pharmaceuticals Technology Research Institute Co., Ltd. romanized | 15 | 15 | 0 |
| 2 | Shaanxi Nian Qing Bao Pharmaceutical Co., Ltd. romanized | 10 | 10 | 0 |
| 3 | Qilu Pharmaceutical Co., Ltd. | 6 | 2 | 4 |
| 4 | Guo Yao Group Gong Ye Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Bristol-Myers Squibb Pharma EEIG | 5 | 1 | 0 |
| 6 | Li Zhu Group Li Zhu Pharmaceutical Factory romanized | 5 | 1 | 0 |
| 7 | Shandong Qidu Pharmaceutical Co., Ltd. | 4 | 2 | 4 |
| 8 | Sanofi-aventis groupe | 4 | 1 | 0 |
| 9 | Atlantic Laboratories Corporation Ltd. | 3 | 1 | 0 |
| 10 | Santen Pharmaceutical Co. Ltd. | 3 | 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
72 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/08/22Import · Class 1 | RO7247669注射液 · No verified English nameJXSL2200139 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd |
| 2022/08/22Import · Class 1 | LOU064片 · No verified English nameJXHL2200248 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2022/08/22Generic · Class 3 | Aripiprazole Oral SolutionCYHS2201311 | Shenyang Tian Bang Pharma Co., Ltd. romanized |
| 2022/08/22Generic · Class 3 | Pimavanserin Tartrate CapsulesCYHL2200072 | Chengdu Kang Hong Pharma Group Co., Ltd. romanized |
| 2022/08/22Generic · Class 3 | Bromhexine Hydrochloride Solution For InhalationCYHL2200070 | Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized |
| 2022/08/22New drug · Class 1 | AK129注射液 · No verified English nameCXSL2200395 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2022/08/22New drug · Class 1 | 重组人源化抗HER2双特异性抗体注射液 · No verified English nameCXSL2200390 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized |
| 2022/08/22New drug · Class 1 | PM8002注射液 · No verified English nameCXSL2200389 | Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized |
| 2022/08/22New drug · Class 1 | GC101 · No verified English nameCXSL2200388 | Shanghai Jing Shan Bio Technology Co., Ltd. romanized |
| 2022/08/22New drug · Class 1 | HLX22单抗注射液 · No verified English nameCXSL2200386 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized |
| 2022/08/22New drug · Class 1 | 斯鲁利单抗注射液 · No verified English nameCXSL2200385 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized |
| 2022/08/22New drug · Class 1 | JS015注射液 · No verified English nameCXSL2200380 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/08/22New drug · Class 1 | TR64片 · No verified English nameCXHL2200606 | Anhui Zhong Ke Tuo Ran Drug Ke Xue Research Co., Ltd. romanized |
| 2022/08/22New drug · Class 2.2; 2.4 | 艾普拉唑微丸肠溶片 · No verified English nameCXHL2200605 | Li Zhu Group Li Zhu Pharmaceutical Factory romanized |
| 2022/08/22New drug · Class 2.2; 2.4 | 艾普拉唑微丸肠溶片 · No verified English nameCXHL2200604 | Li Zhu Group Li Zhu Pharmaceutical Factory romanized |
| 2022/08/22New drug · Class 2.2; 2.4 | 艾普拉唑微丸肠溶片 · No verified English nameCXHL2200602 | Li Zhu Group Li Zhu Pharmaceutical Factory romanized |
| 2022/08/22New drug · Class 2.2; 2.4 | 艾普拉唑微丸肠溶片 · No verified English nameCXHL2200601 | Li Zhu Group Li Zhu Pharmaceutical Factory romanized |
| 2022/08/22New drug · Class 2.2 | 艾普拉唑微丸肠溶片 · No verified English nameCXHL2200600 | Li Zhu Group Li Zhu Pharmaceutical Factory romanized |
| 2022/08/19Generic · Class 3 | Sodium Bicarbonate Ringer’s InjectionCYHS2201348 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2022/08/19Generic · Class 3 | Sodium Bicarbonate Ringer’s InjectionCYHS2201347 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2022/08/19Generic · Class 3 | Peramivir InjectionCYHS2201341 | Hainan Huluwa Pharmaceutical Group Co., Ltd. |
| 2022/08/19Generic · Class 3 | Gallium[68Ga ] Dotatate InjectionCYHL2200068 | Yuan Zi Gao Ke Co., Ltd. romanized |
| 2022/08/19Generic · Class 3 | Kit For The Preparation Of Gallium Ga 68 Dotatate InjectionCYHL2200067 | Yuan Zi Gao Ke Co., Ltd. romanized |
| 2022/08/19New drug · Class 3.3 | 注射用重组人促卵泡激素 · No verified English nameCXSL2200384 | Chengdu Jing Ze Biopharmaceutical Co., Ltd. romanized |
| 2022/08/19New drug · Class 2.1 | 人干扰素α1b吸入溶液 · No verified English nameCXSL2200383 | Shenzhen Ke Xing Pharma Co., Ltd. romanized |
| 2022/08/19New drug · Class 2.1 | 人干扰素α1b吸入溶液 · No verified English nameCXSL2200382 | Shenzhen Ke Xing Pharma Co., Ltd. romanized |
| 2022/08/19New drug · Class 1 | 注射用重组人源化抗HER2单抗-AS269偶联物(ARX788) · No verified English nameCXSL2200381 | Zhejiang Xin Ma Biopharmaceuticals Co., Ltd. romanized |
| 2022/08/19New drug · Class 1 | STC007注射液 · No verified English nameCXHL2200599 | Chengdu Nuo He Cheng Tai Bio Technology Co., Ltd. romanized |
| 2022/08/19New drug · Class 1 | JAB-2485片 · No verified English nameCXHL2200598 | Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized |
| 2022/08/19New drug · Class 1 | JAB-2485片 · No verified English nameCXHL2200597 | Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized |
42 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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